BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2832658 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02131
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 8, 2012
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL BED-2, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 13 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1114836 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. PER THE DEALER, THE END USER HAS THE MEDICAL CONDITIONS OF CEREBAL PALSY AND RESPIRATORY ABNORMALITIES, AND IS UNABLE TO CARE FOR HIMSELF. HE IS UNABLE TO WALK AND USES A WHEELCHAIR ON A REGULAR BASIS. THIS IS THE SECOND OF THREE REPORTED INCIDENTS INVOLVING THE SAME END USER AND DEVICE. THE MALE CONSUMER'S AGE IS (B)(6), 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT THE END USER WAS FOUND TO HAVE HIS HEAD ENTRAPPED. IN THIS INSTANCE HIS HEAD WAS WEDGED BETWEEN THE PUMPER PAD AND THE BED RAIL. NO ISSUES IN GETTING HIM UNTRAPPED. DATE OF INCIDENT UNKNOWN. MDR FILED. (THIS IS THE SECOND OF THREE REPORTED INCIDENTS INVOLVING THE SAME END USER AND DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN BED-2

    Patients

    Seq Age Sex Outcome Treatment
    1 20 Other