BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2841576 · Received October 22, 2012

    Report

    Report Number
    1831750-2012-11083
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: BRAKE CAM BOLTS MALFUNCTIONED. BRAKE CRANK ASSEMBLIES HAD TO BE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTEND BRAKES WERE NOT HOLDING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1