BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3283538 · Received August 12, 2013

    Report

    Report Number
    3004493922-2013-01768
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Report Date
    July 30, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    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 # 3004493922-2013-01768, INDICTING THE BRAND NAME AS AN AC POWERED PATIENT 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 THAT A ROZE PATIENT LIFT HAD A BENT BOOM ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385789 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU ROZE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other