BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CRITICAL CARE BED

    MDR report key: 2112506 · Received May 25, 2011

    Report

    Report Number
    1831750-2011-05032
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL PANELS WERE BROKEN APART AND THERE WERE SHARP EDGES AND ALSO AREAS WHERE FLUID COULD INGRESS. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM CRITICAL CARE BED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 2040 NA

    Patients

    Seq Age Sex Outcome Treatment
    1