BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2798423 · Received October 22, 2012

    Report

    Report Number
    1031452-2012-00245
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 19, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    OSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL BAR600IVC, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1123842, REV.H(APR-11), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. A CALL WAS PLACED TO THE INITIAL REPORTER, HOWEVER, NO FURTHER DETAIL WAS PROVIDED, THEREFORE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATES THE LEFT WHEEL ON THE HEAD OF THE BED BUCKLED AND BROKE. THE BROKEN CASTER IS BEING REPLACED UNDER WARRANTY. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 OSI INVACARE FLORIDA OPERATIONS BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other