BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 3123211 · Received May 21, 2013

    Report

    Report Number
    1031452-2013-00947
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE IS (B)(4) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS UNTIL (B)(4) 2013 FOR PROCESSING.

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE BED HAD AN UNKNOWN INVACARE BED. THIS ISSUE COULD CAUSE THE BED TO COLLAPSE WITH THE USER IN IT CAUSING THEM INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224501 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other