BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3257006 · Received July 31, 2013

    Report

    Report Number
    3004493922-2013-01679
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Report Date
    July 16, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)- FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 3004493922-2013-01679, 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

    IT WAS REPORTED THE ACTUATOR ON THE RPS350-1 POWERED LIFT IS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358536 NON AC-POWERED PATIENT LIFT 880.5510 FNG INVACARE SUZHOU RPS350-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other