BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2912522 · Received January 12, 2013

    Report

    Report Number
    9616091-2013-00066
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    January 12, 2013
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER STATES THAT THE LIFT IS HARD TO MOVE THE WHEELS. SEEMS TO BE MORE RESISTENT THAN THE OTHER LIFT HE HAS WHICH IS THE SAME MODEL. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19268 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other