BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2444366 · Received February 9, 2012

    Report

    Report Number
    1031452-2012-00017
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Report Date
    February 7, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL IVC CEF0003-01 DETERMINED THAT THIS IS AN MDR. (B)(4). MODEL BAR600IVC, SERIAL NUMBER/DATE CODE (B)(4) WAS APPROXIMATELY 2 YEARS OLD AT THE TIME OF THE INCIDENT. THE USER MANUAL PART NUMBER 1123842 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL COULD ALSO BE FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAD FULLY READ AND UNDERSTOOD THE USER MANUAL. DOCUMENTATION PROVIDED WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DID NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD HAVE CONTACT INVACARE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE UNIT BURNED UP ON THE INSIDE AND BUBBLED UP. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other