BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3021789 · Received March 26, 2013

    Report

    Report Number
    0001831750-2013-02535
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION AND REPAIR COMPLETE ON THE CPR RELEASE AND BRAKE PEDALS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE BED WAS NOT FUNCTIONING. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE MANUAL CPR RELEASE WOULD NOT FUNCTION AND BOTH BRAKE PEDALS WERE DAMAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123608 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1