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Adverse Event Report

ABBOTT MANUFACTURING, INC. ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER   back to search results
Catalog Number 7A83-01
Event Date 02/02/2000
Event Type  Malfunction  
Event Description

Customer stated the gas springs on the axsym failed and hit tech in the head.

 
Manufacturer Narrative

The gas springs (part no. 14724-007) failed to hold the processing carousel cover open and the lid fell and hit the customer in the head. No permanent injury reported. The gas springs on the lid were replaced to resolve the issue. Tsb 83-069 was released worldwide in december, 1999 to the field service organizations to proactively replace the gas springs during the next service call as deterioration of the part is noted. Additionally, a product information letter (pi 1002-2000) was issued january 13, 2000 to notify customers that the gas springs may lose their ability to completely support the weight of the processing center cover due to wear and tear from day to day operations. The letter instructs the customer to use caution when opening the processing center cover as it may unexpectedly close. The customer stated that they do not know when they received the product information letter. This is the final report.

 
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Brand NameABBOTT AXSYM SYSTEM
Type of DeviceAUTOMATED IMMUNOASSAY ANALYZER
Baseline Brand NameAXSYM ANALYZER MASTER PCK
Baseline Generic NameAUTOMATED IMMUNOASSAY ANALYZER
Baseline Catalogue Number7A83-01
Baseline Device FamilyAXSYM
Baseline Device 510(K) NumberK950915
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/30/1993
Manufacturer (Section F)
ABBOTT MANUFACTURING, INC.
1921 hurd dr.
irving TX 75038
Manufacturer (Section D)
ABBOTT MANUFACTURING, INC.
1921 hurd dr.
irving TX 75038
Manufacturer Contact
paul landesman
200 abbott park
abbott park , IL 60064-3500
(847) 937 -2688
Device Event Key260540
MDR Report Key269124
Event Key252315
Report Number1628664-2000-00011
Device Sequence Number1
Product CodeJJE
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 02/29/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7A83-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1995
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Reuse

Database last updated on January 30, 2009

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