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Adverse Event Report

ABBOT MANUFACTURING, INC. ABBOTT AXSYM SYSTEM AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS   back to search results
Catalog Number 7A83-01
Event Date 07/07/1999
Event Type  Malfunction  
Event Description

Axsym lid fell on customer's head. Customer stated that has a bad headache, but no bump or cut is present. No further info was provided.

 
Manufacturer Narrative

Pt info was not provided by the account. The gas shocks (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 fsr replaced the gas shocks on the lid to resolve the issue. Proactive replacement of the gas shocks does occur by field svc when normal wear and tear results in unsmooth operation or failure of the shocks to hold the lid up. Implementation of isa 123a in october 1998 was released worldwide to the field svc organizations to proactively replace the gas shocks during yearly pm maintenance as deterioration of the part is noted. This is the final report.

 
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Brand NameABBOTT AXSYM SYSTEM
Type of DeviceAUTOMATED SYSTEM FOR THE PROCESSING OF EIAS
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)
ABBOT MANUFACTURING, INC.
1921 hurd dr.
irving TX 75038
Manufacturer (Section D)
ABBOT MANUFACTURING, INC.
1921 hurd dr.
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1921 hurd dr.
irving TX 75038
Manufacturer Contact
paul landesman, ph.d
100 abbott park rd
dept 09d5, ap6c-6
abbott park , IL 60064-3500
(847) 937 -2688
Device Event Key227809
MDR Report Key235065
Event Key220545
Report Number1628664-1999-00040
Device Sequence Number1
Product CodeJJE
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/28/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device Catalogue Number7A83-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1994
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 February 28, 2009

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