BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2781801 · Received October 11, 2012

    Report

    Report Number
    1031452-2012-00231
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    August 29, 2012
    Report Date
    October 10, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH820-3MDLX, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 10 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1134871, REV.G (FEB-09) 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 CONSUMERS 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 MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED. THE INITIAL REPORTER WAS CONTACTED FOR ADDITIONAL DETAIL ON THIS INCIDENT. IF ADDITIONAL INFORMATION REGARDING THIS INCIDENT IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN INCIDENT REGARDING A BROKEN WELD ON THE BOTTOM CARRIAGE FRAME ASSEMBLY ON THIS BED WAS RECEIVED. IN SPEAKING WITH THE REPORTER, IT WAS LEARNED THE FACILITY IDENTIFIED THIS ISSUE AND IDENTIFIED THAT THEY WANTED TO REMOVE THE END USER FROM THE BED. ON THE DAY SCHEDULED TO REPLACE THE BED, THE END USER REPORTEDLY WAS FOUND IN THE BED WITH THE FRAME ALREADY ON THE FLOOR. NO REPORTED INJURY HAD OCCURRED. THE DEVICE IS BEING REPLACED.

    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 IH820-3MDLX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other