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Health Devices Alerts® (HDA), produced by ECRI, is a comprehensive database of reported medical device problems, hazards, recalls, evaluations, and updates. The selections derive from an extensive review of the medical, legal, and technical literature, various national reporting networks and government sources, and ECRI'S own international problem reporting network. Each entry is indexed using ECRI's internationally endorsed Universal Medical Device Nomenclature System (UMDNS). An online thesaurus is available to assist in locating broader, narrower, and related product names. A complete directory of medical devices and manufacturers is available in a companion database, File 188, ECRI's Health Devices Sourcebook®.
HDA covers reports of problems, evaluations, and technology assessments of diagnostic and therapeutic medical equipment and related materials, ranging from sutures to magnetic resonance imaging units, including implanted devices and related accessories, disposable medical products, clinical laboratory reagents, and selected hospital furniture, casework, and systems.
USE FILE 198
to track medical device problems, hazards, recalls, evaluations, and updates.
USE /CO OR CO=
to find companies of interest.
USE /PN OR PN=
to find product names of interest.
HDA covers reports of problems with diagnostic and therapeutic medical equipment and related materials, including:
HDA contains four major types of information relating to medical devices: 1) abstracts (ABS) of articles from the published literature, 2) action items (AI) that ECRI has investigated or verified, 3) Problem Reporting Program (PRP) records from the voluntary, spontaneous reporting system operated by the U.S. Food and Drug Administration (FDA), and 4) Medical Device Reporting (MDR) records from the mandatory reporting system operated by the FDA.
|Dates Covered:||1977 to 2000 (Abstracts); 1982 to 2000 (AI); 1984 to 1996 (MDR); 1977 to 1992 (PRP)|
|File Size:||More than 683,000 records|
|PRODUCTS||Industrial and Consumer|
Health Devices Alerts is produced by ECRI, an independent, non-profit agency that evaluates health care technologies. Questions concerning file content should be directed to:
5200 Butler Pike
Plymouth Meeting, PA 19462
For Dialog's Redistribution and Archive Policy, enter HELP ERA online. The following terms and conditions also apply.
Health Devices Alerts and the medical device terms and numerical codes used therein are owned and copyrighted by ECRI. ECRI authorizes the use of such terms and codes solely for the customer's internal use. All bibliographic information and record identification information in Health Devices Alerts are owned and copyrighted by ECRI. Health Devices Alerts may not be disseminated, reproduced, or in any way made available to any third party or be used for any commercial purpose whatsoever without the prior written consent of ECRI. Requests for permission should be addressed to: Permissions Editor, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462.
ECRI MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE ACCURACY, QUALITY, VALIDITY, OR COMPLETENESS OF THIS DATABASE OR THE INFORMATION THEREIN. In no event shall ECRI be liable for any lost profits, or indirect or consequential damages and in no event shall ECRI's liability exceed the cost of the online database search charge for the specific information giving rise to such liability. Listing a specific model and brand of device does not in itself justify deferring a purchase or taking equipment out of service without further investigation, nor does it imply that competing devices are safer or more appropriate. Although each MDR report reflects an actual incident, readers are urged to use the information with caution. The cause of an injury or death may not have been established, and the presence of a report in this database does not reflect a judgment by the manufacturer, the FDA, or ECRI that a device defect exists or that the device was responsible for the reported death or injury.
|File 198:Health Devices Alerts(R)|
|(c) 1997 ECRI-nonprft agncy|
|AN=, SF=||00027683 ABS-15894; AI-A1333 SUBFILE: ABS|
|PC=, /PN, PN=||PRODUCT(s):13-209 PUMPS, ENTERAL FEEDING|
|/DE||COMMON DEVICE NAME: Kangaroo 220 and 330 Enteral Feeding Pumps|
|/ID||IDENTIFIER: Pumps manufactured prior to June 1985|
|/CO, CO=||MANUFACTURER: Sherwood Medical Co. Sub American Home Products|
|(101927), 1831 Olive St, St Louis Mo 63103|
|/TX||ECRI recently received a report involving overinfusion associated|
|with a Kangaroo 330 Enteral Feeding Pump. Over infusion resulted|
|when the pump set was incorrectly installed behind the rotor. To|
|help prevent incorrect installation, Sherwood Medical modified the|
|rotors on the Kangaroo 220 and 330 pumps. In June 1985, Sherwood|
|Medical informed ECRI that it will exchange rotors on pumps|
|manufactured prior to June 1985 for the modified ones, free of|
|charge. (Rotors manufactured prior to June 1985 are metal; the new|
|rotors are plastic.) It emphasizes that most situations involving|
|overinfusion result from user error and can be avoided by following|
|the instructions for correct placement of the set on the rotor. These|
|directions appear in the pump's operating manual, on the pump itself|
|and on the pump set. Hospitals should ensure that all users are|
|familiar with proper assembly and follow user instructions for the|
|Kangaroo 220 and 330 Enteral Feeding Pumps. To help prevent incorrect|
|installation of the pump set, replace all old metal rotors in your|
|Kangaroo 220 and 330 pumps with the modified ones. To order|
|replacement rotors or for more information, contact Sherwood Medical|
|Customer Service, Watertown, NY, at (800) 448-0190: in New York,|
|SO=||SOURCE: ECRI, Manufacturer|
|PD=||PUBLICATION DATE: 8905|
|File 198:Health Devices Alerts(R)|
|(c) 1997 ECRI-nonprft agncy|
|AN=, SF=||00027825 MDR-157579 SUBFILE: MDR|
|PC=, /PN, PN=||PRODUCT(s): 10-727 CATHETERS, INTRAVENOUS, PERIPHERAL|
|/DE||COMMON DEVICE NAME: SUBCLAVIAN JUGULAR CATHETER SET|
|/ID||IDENTIFIER: MODEL NA CATALOG 38-755-1|
|/CO, CO=||MANUFACTURER: Deseret Medical, Inc.|
|/TX||DURING ATTEMPTED PLACEMENT OF 16 GAUGE 12 IN CV CATHETER IN LEFT|
|SUBCLAVIAN FOR ADMINISTRATION OF TPN, THE TIP PORTION OF CATHETER|
|FRACTURED OFF PT TAKENTO OR THE EMBOLIZED CATHETER FRAGMENT WAS|
|REMOVED. APPARENTLY THE CATHETER PORTION WAS DISCARDED AFTER THE|
|CATHETER PORTION WAS DISCARDED AFTER EVENT. CO'S DIRECTIONS FOR|
|CAUTION AGAINST WITHDRAWING CATHETER AGAINST NEEDLE BEVEL AS,|
|CATHETER MAY BE CUT, SEE DIRECTIONS FOR USE AS PACKAGED WITH|
|INDIVIDUAL SUBCLAVIAN CATHETER AND ALSO PRESENT ON A 8 x 10 SHEET IN|
|EACH BOX OF PRODUCT.|
|SO=||SOURCE: M.D.R. REPORT DATED 9/02/88|
|/TX||ECRI COMMENT: This user error is reported virtually every month.|
|FP=||FDA PRODUCT CODE: DQO|
|MANUFACTURER DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21|
|CFR 803. DESERET MEDICAL DOES NOT CONSIDER THIS REPORT OR ITS|
|CONTENTS TO BE AN ADMISSION THAT A DESERET PRODUCT IS DEFECTIVE OR|
|THAT A DESERET PRODUCT HAS CAUSED A DEATH OR SERIOUS INJURY.|
|None||None||All Basic Index Fields||Word||S CATHETERS(W)CENTRAL(W)VENOUS|
|/CO||CO||Company Name1||Word||S SHERWOOD(W)MEDICAL/CO|
|/DE||DE||Common Device Name||Word||S KANGAROO(W)220/DE|
S PUMPS, ENTERAL FEEDING/PN
|/TX||TX||Abstract, Problem, Action Needed, Comments||Word||S (OVERINFUSION AND KANGAROO)/TX|
1 Searchable in the Basic Index and in the Additional Indexes.
|None||AN||DIALOG Accession Number|
|AN=||AN||ECRI Accession Number||Phrase||S AN=ABS-15894|
|CO=||CO||Company Name1||Word||S CO=(BECTON(W)DICKINSON)|
|ET=||ET||Effect Type3||Phrase||S ET=SERIOUS INJURY|
|FP=||FP||FDA Product Code||Phrase||S FP=DQO|
|PC=||PC||Product Code2||Phrase||S PC=13-209|
|PD=||PD||Publication Date of Record Entry||Phrase||S PD=198905|
S PN=PUMPS, ENTERAL FEEDING
|None||RF||ECRI Reference Accession Number|
|SO=||SO||Source Information4||Word||S SO=(ECRI(W)MANUFACTURER)|
2 Product codes are assigned to specific medical devices. When no product codes exist for very broad classifications of medical devices, PC=00-000 is assigned.
3 Available only in MDR subfile.
4 Display includes Journal Name, Volume, Pagination, and Publication Date.
5 MDR is available only in 1984-1996.
6 PRP is available only in 1977-1992.
7 UD index is present only from UD=199909 forward.
|/ABS||Abstract Present||SELECT S2/ABS|
|/AI||Action Items Records||SELECT S3/AI|
|/MDR||Medical Device Reports Records5||SELECT S2/MDR|
|/PRP||Product Review Problems Records6||SELECT S3/PRP|
|CO, PD, PN, SF||SORT S6/ALL/CO|
|All phrase- and numeric-indexed fields in the Additional Indexes can be ranked.||RANK ET|
RANK PN S4
|Display codes listed in the Search Options tables can be used to customize output.||TYPE S3/PC,PN,CO,DE/1-5|
|1||--||DIALOG Accession Number|
|2||--||Accession Numbers, Subfile,Product Name and Product Code, Common Device Name, Identifier, Company Information, Source, Publication Date, Effect Type, ECRI Comment, FDA Product Code, Manufacturer Disclaimer|
|3||Medium||Accession Numbers, Subfile, Product Name and Product Code, Source|
|4||--||Full Record with Tagged Fields|
|6||Free||Accession Numbers, Subfile, Product Name and Product Code, and Common Device Name|
|7||Long||Accession Numbers, Subfile, Product Name and Product Code, and Abstract|
|8||Short||Accession Numbers, Subfile, Product Name and Product Code, Publication Date, and Effect Type|
|K||--||KWIC (Key Word In Context) displays a window of text; may be used alone or with other formats|
|If the accession number of a specific record is known, it can be used to display the record directly.||TYPE 00027683/5
Rates For File: Health Devices Alerts® Standard Subscrib Cost per DialUnit: $6.89 $6.36 Cost per Minute: $2.02 $1.85 Rank Elements $0.00 $0.00 << Standard >> << Subscriber >> Format Types Prints Types Prints 1 $0.00 $0.00 $0.00 $0.00 2 $5.00 $5.00 $2.20 $2.20 3 $2.00 $2.00 $1.10 $1.10 4 $5.00 $5.00 $2.20 $2.20 5 $5.00 $5.00 $2.20 $2.20 6 $0.00 $0.00 $0.00 $0.00 7 $4.00 $4.00 $1.10 $1.10 8 $0.00 $0.00 $0.00 $0.00 9 $5.00 $5.00 $2.25 $2.25 KWIC95 $0.40 NA $0.00 NA KWIC96 $0.40 NA $0.00 NA REDIST/COPY Multiplier Table: Range Multiplier 1-2 1.00 3-25 1.50 26-100 3.00 101-200 4.00 201-500 6.00 501-1000 8.00 1001 or more 10.00 ARCHIVE Multiplier Table: Range Multiplier 1-25 1.50 26-200 3.00 201-500 6.00 501-1000 8.00 1001 or more 10.00