BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 2990431 · Received March 5, 2013

    Report

    Report Number
    0001831750-2013-01750
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT A COMPONENT BURNED ON THE MOTOR CONTROL BOARD. FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY CUSTOMER WHICH DETERMINED THE BED HAD NO POWER DUE TO A DAMAGED MAIN CONTROL BOARD AND DAMAGED FUSES. CUSTOMER PERFORMED REPAIRS. CUSTOMER PERFORMED EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED HAD NO POWER DUE TO A DAMAGED MAIN CONTROL BOARD AND DAMAGED FUSES. 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 VIA REPAIR WORK ORDER THAT A COMPONENT BURNED ON THE MOTOR CONTROL BOARD. 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
    93547 UNKNOWN_MEDICAL_PRODUCT UNKNOWN FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1