BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PATIENT ROTATION BED

    MDR report key: 2802214 · Received October 23, 2012

    Report

    Report Number
    1031452-2012-00246
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 21, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL BED4-1633, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY FOUR MONTH OLD. THE CONSUMER IS (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) - THE DEALER REPORTED THAT THE BED4-1633 PATIENT BED HAND CONTROL AND PRESS DOWN BUTTON FOR BOTH HEAD AND FOOT END KEPT ON GOING DOWN FURTHER THAN THE CONSUMER WANTS IT TO. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED PATIENT ROTATION BED 890.5225 IKZ INVACARE FLORIDA OPERATIONS BED4-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other