BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2140753 · Received June 15, 2011

    Report

    Report Number
    1313850-2011-00144
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: COLD SOLDER JOINT CAUSED TRACE ON PC BOARD TO FAIL. IT SHOULD BE NOTED THAT THE UNIT WAS RETURNED TO MFR IN NON-FUNCTIONING CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE BOARD WAS ARCING AND BURNING. NO PT 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 TP500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1