BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP PUMP TEMPERATURE

    MDR report key: 2119698 · Received May 27, 2011

    Report

    Report Number
    1313850-2011-00123
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT WAS NOT FUNCTIONING PROPERLY. UPON EVAL, EVIDENCE OF FLUID INGRESS WAS DETECTED AND THE WELL THERMOSTAT AND SENSOR BRACKET WERE CORRODED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1