BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3261972 · Received August 2, 2013

    Report

    Report Number
    9616091-2013-01419
    Event Type
    Malfunction
    Date Received
    August 2, 2013
    Report Date
    July 19, 2013
    Manufacturer
    INVAMEX
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT # 9616091-2013-01419 INDICTING THE BRAND NAME AS AC POWERED LIFT WITH A COMMON DEVICE NAME OF 880.5500. THE CORRECT BRAND NAME IS NON-AC POWERED PATIENT LIFT WITH A COMMON DEVICE NAME OF 880.5510.

    Description of Event or Problem · 1

    DEALER SAYS THE UNIT GOES UP BUT NOT DOWN. HE SAID HE TRIED PENDANTS BUT THE SAME PROBLEM. HE SAID HE HAS UNPLUGGED THE ACTUATOR AND PLUGGED IT IN AS HARD AS HE COULD BUT THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363747 NON AC-POWERED PATIENT LIFT 880.5510 FNG INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other