BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 1032667 · Received April 22, 2008

    Report

    Report Number
    1628664-2008-00101
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: GAS SHOCK. THE ABBOTT COMMANDER PARALLEL PROCESSING CENTER (LN 06208-86) HAD A DAMAGED COVER SPRING ON THE LEFT SIDE OF THE PROCESSOR, SO THE LID WOULD NOT STAY OPEN. NO INJURIES WERE REPORTED AS A RESULT OF THE DAMAGED SPRING. A NEW SPRING WAS SENT TO THE CUSTOMER FOR INSTALLATION. THE CUSTOMER INSTALLED THE SPRING AND VISUALLY VERIFIED THE PROPER OPERATION. A REVIEW OF THE COMPLAINT HISTORY FOR ABBOTT COMMANDER PARALLEL PROCESSING CENTER (LN 06208-86) WAS PERFORMED FOR THE TIME PERIOD OF 2008. NO RELATED COMPLAINTS WERE IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ABBOTT FIELD SERVICE REP WAS AT THE ACCOUNT SITE AND DISCOVERED THE SPRING ON THE LEFT LID COVER OF THE COMMANDER PPC WAS DAMAGED AND NEEDED TO BE REPLACED. THE LID WAS NOT HOLDING UP AS EXPECTED BECAUSE OF THE DAMAGED SPRING. NO INJURY WAS REPORTED DUE TO COMMANDER PPC LID NOT STAYING OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS JQW ABBOTT MANUFACTURING INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA GAS SPRING-MOD. TOP COVER