BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2991810 · Received March 6, 2013

    Report

    Report Number
    1031452-2013-00480
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER PROVIDER THE WELD IS NOT ALLOWING THE HEADSPRING TO ENGAGE FULLY INTO THE FOOTSPRING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95161 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR5000IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other