BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2504688 · Received March 27, 2012

    Report

    Report Number
    1031452-2012-00034
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Report Date
    March 26, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL BAR600IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1123842 REV H (APR-11) 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL BAR600IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1123842 REV H (APR-11) 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 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. (B)(4) - DEVICE EVALUATION COMPLETED. CONDITION OF RETURN: THE PENDANT APPEARS TO BE USED AND IN POOR CONDITION. RESULT ANALYSIS: VISUAL: THE PENDANT WAS IN POOR CONDITION. THE CORD WAS CUT IN SEVERAL AREAS EXPOSING THE INTERNAL WIRES. ONE OF THE AREAS WAS COVERED WITH A BANDAGE. THE ENTIRE PENDANT WAS COVERED IN DUST. FUNCTIONAL: THE PENDANT WAS NOT FUNCTIONALLY TESTED DUE TO THE DAMAGE AND THE EXPOSED INTERNAL WIRES. THERE WAS NO EVIDENCE OF MELTING. CONCLUSION: THE PENDANT HAD SEVERE DAMAGE TO THE CORD. WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THE DAMAGE. THE COMPLAINT DOCUMENTED THE PRODUCT USED AS A BAR600IVC, SERIAL #(B)(4). A REVIEW OF THIS DHR WAS CONDUCTED WITH NO ISSUES FOUND. THE BED WAS PRODUCED AND RELEASED (B)(4) 2011.

    Description of Event or Problem · 1

    DEALER STATED THAT THE WIRES ON HAND CONTROL ARE ALLEGEDLY MELTED. REPLACEMENT ORDER # (B)(4). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER STATED THAT THE WIRES ON HAND CONTROL ARE ALLEGEDLY MELTED. REPLACEMENT ORDER #(B)(4). NO INJURY ALLEGED.

    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 BAR600IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other