BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2863719 · Received December 10, 2012

    Report

    Report Number
    9616091-2012-00619
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER CAREGIVERS

    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

    CARETAKER OF THE USER STATED THAT THE PATIENT WAS STUCK IN THE AIR IN A GRPL450-1 PATIENT LIFT AS THE LIFT COULD NOT BE LOWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX GRPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other