BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PATIENT ROTATION BED

    MDR report key: 2492205 · Received March 15, 2012

    Report

    Report Number
    1031452-2012-00030
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 25, 2012
    Report Date
    March 14, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 5310IVC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS 2 MONTHS 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 DEVISE HAS BEEN DESCRIBED BY THE DEALER AS LEANING UP AGAINST THE BED RAIL WHILE THEY ARE IN BED ALLEGEDLY CAUSING THE BED RAIL TO RELEASE. NO INJURY. INVACARE BED RAILS WARN THAT "BED RAILS ARE INTENDED TO PREVENT AN INDIVIDUAL FROM INADVERTENTLY FALLING OUT OF BED. DO NOT USE FOR RESTRAINT PURPOSES". ALTHOUGH BED RAILS ARE NOT RATED TO ANY SPECIFIC WEIGHT LIMITATIONS, THE BED RAILS MAY BECOME DEFORMED OR BROKEN IF EXCESSIVE SIDE PRESSURE IS EXERTED ON THE BED RAILS. THE BED RAIL IS NOT AN ASSIST RAIL FOR GETTING INTO AND OUT OF BED. AFTER ANY ADJUSTMENTS, REPAIR OR SERVICE AND BEFORE USE, MAKE SURE ALL ATTACHING HARDWARE IS TIGHTENED SECURELY. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DELER STATED THAT THE BED RAIL IS ALLEGEDLY FALLING DOWN. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED PATIENT ROTATION BED 890.5225 IKZ INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other