BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2930731 · Received January 28, 2013

    Report

    Report Number
    1031452-2013-00155
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CONSUMER THE BED GETS STUCK AND WILL NOT GO DOWN UNLESS IT IS PUSHED ON AND IT SLAMS DOWN AT TIMES. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37489 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5490IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other