BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2133823 · Received May 12, 2011

    Report

    Report Number
    1313850-2011-00105
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: CRACKED COVER AND TRAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT'S COVER AND TRAY WERE CRACKED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMP PUMP TEMPERATURE PUMP DWJ STRYKER CORP DBA GAYMAR TP500C NA

    Patients

    Seq Age Sex Outcome Treatment
    1