BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2821880 · Received November 6, 2012

    Report

    Report Number
    3003433498-2012-00046
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IS UNKNOWN, SERIAL NUMBER/DATE CODE (B)(4). THE OWNER'S MANUAL PART WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE FACILITY 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 . THE RESIDENT'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE RESIDENT'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE FACILITIES TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    FACILITY CALLED STATING THAT THE HEAD DECK ON THE UNKNOWN CARROLL HEALTHCARE BED IS ALLEGEDLY BENT. REPLACEMENT PART HAS BEEN ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL CARROLL HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other