BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PATIENT ROTATION BED

    MDR report key: 2930589 · Received January 28, 2013

    Report

    Report Number
    1031452-2013-00154
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATING FOOT SECTION LOWERING ON ITS OWN. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37105 POWERED PATIENT ROTATION BED 890.5225 IKZ INVACARE FLORIDA OPERATIONS 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other