BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 3190652 · Received June 26, 2013

    Report

    Report Number
    0001831750-2013-05815
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY THE CUSTOMER WHO DETERMINED THR FOWLER WAS DRIFTING DUE TO A FAULTY MOTOR. THE SERIAL NUMBER OF THE BED COULD NOT BE PROVIDED BY THE CUSTOMER AS THE BED WAS REPAIRED AND PLACED BACK IN SERVICE BY THE CUSTOMER AND THE SERIAL NUMBER WAS NOT RECORDED. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOWLER WOULD DRIFT DUE TO FOWLER CLUTCH MALFUNCTION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOWLER WOULD DRIFT DUE TO A FAULTY MOTOR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290115 UNKNOWN_MEDICAL_PRODUCT UNKNOWN FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1