BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2682050 · Received August 4, 2012

    Report

    Report Number
    1031452-2012-00141
    Event Type
    Malfunction
    Date Received
    August 4, 2012
    Report Date
    August 13, 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) ISSUED MFG REPORT #1031452-2012-00141 SHOWING THE TYPE OF REPORTABLE EVENT, AS A DEATH. THE CORRECT SELECTION SHOULD HAVE BEEN MALFUNCTION AS IT WAS THE HI/LO FUNCTION ON THE 5410IVC BED THAT WAS NOT WORKING CORRECTLY. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 5410IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1114836 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 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)(6) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 5410IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1114836 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 CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN 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

    "DEALER STATES THE HI/LO FUNCTION WAS NOT WORKING. ADVISED TO SWAP MOTORS LEADS AND CHECK HAND CONTROL FOR CONNECTIVITY. AFTER TROUBLESHOOTING HE NEEDS TO REPLACE THE CONTROL (JUNCTION) BOX. NO PARTS BEING REPLACED TODAY. DEALER WILL CALL BACK TO CHECK IF HE WANTS TO ORDER." NO ALLEGED INJURY.

    Description of Event or Problem · 1

    "DEALER STATES THE HI/LO FUNCTION WAS NOT WORKING. ADVISED TO SWAP MOTORS LEADS AND CHECK HAND CONTROL FOR CONNECTIVITY. AFTER TROUBLESHOOTING HE NEEDS TO REPLACE THE CONTROL (JUNCTION) BOX. NO PARTS BEING REPLACED TODAY. DEALER WILL CALL BACK TO CHECK IF HE WANTS TO ORDER." NO ALLEGED 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 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other