BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2843944 · Received November 23, 2012

    Report

    Report Number
    1031452-2012-00292
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 23, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE OWNER'S MANUAL PART NUMBER (B)(4), REV.F, (AUG-07) 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. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S 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

    PROVIDER STATES THAT THE HEAD SECTION OF BED WELD BENT AND BROKEN. IN SPEAKING WITH THE REPORTER IT WAS LEARNED THIS UNIT HAS JUST RECENTLY BEEN PLACED IN SERVICE. THERE WAS NO REPORT OR ANY INFORMATION OF HARM OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 Other