BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3256907 · Received July 31, 2013

    Report

    Report Number
    9616091-2013-01373
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Report Date
    July 15, 2013
    Manufacturer
    INVAMEX
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 9616091-2013-01373 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

    CUSTOMER STATES THE LIFT AUTOMATICALLY OPERATES DOWN WHEN PERSON IS ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358708 NON AC-POWERED PATIENT LIFT 880.5510 FNG INVAMEX RPA450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other