BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2912581 · Received January 13, 2013

    Report

    Report Number
    1031452-2013-00085
    Event Type
    Malfunction
    Date Received
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) IT WAS REPORTED BY THE CONSUMER CAREGIVER THAT THE 5310IVC BED WITH RAILS AND TRAPEZE WAS CONCAVING IN THE MIDDLE AND THE FEET WERE BENT OUTWARD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19623 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other