BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K MOD 107

    MDR report key: 2119701 · Received May 27, 2011

    Report

    Report Number
    1313850-2011-00120
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STRYKER CORP DBA GAYMAR
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT WAS OVERHEATING AND WHEN THE PM WAS DONE, THE WELL THERMOSTAT WAS ALLOWING IT TO OVERHEAT. UPON EVAL OF THE RETURN, EVIDENCE OF FLUID INGRESS WAS DETECTED, AND THE WELL THERMOSTAT AND SENSOR BRACKET WERE FOUND CORRODED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K MOD 107 PUMP FOH STRYKER CORP DBA GAYMAR 64N07700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1