BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLORENCE DC W/REGULAR SIDERAIL

    MDR report key: 3230030 · Received July 16, 2013

    Report

    Report Number
    0001831750-2013-06392
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT WHEN THE MANUAL CPR IS ENGAGED THERE IS A LOSS OF BED MOTOR FUNCTIONS DUE TO MICRO SWITCH MISALIGNMENT. 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
    328713 FLORENCE DC W/REGULAR SIDERAIL BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1