BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2243256 · Received September 1, 2011

    Report

    Report Number
    1313850-2011-00374
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - DAMAGED HOUSING. IT SHOULD BE NOTED THE UNIT ALSO HAD A NON-FUNCTIONING ON/OFF SWITCH, SO THE DEVICE COULD NOT BE POWERED ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT'S HOUSING WAS DAMAGED, EXPOSING ACCESSIBLE HIGH VOLTAGE MOTOR TERMINALS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1