BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3031681 · Received April 2, 2013

    Report

    Report Number
    3004493922-2013-00706
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES: AT 12:00 AM, ON (B)(6) 2013, CALL TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: RELIANT 600 LIFT. IT WAS REPORTED THAT THE FOLLOWING OCCURRED AT 12:00 AM ON (B)(6) 2013: RESIDENT WAS IN SLING IN THE BATHROOM GETTING A SHOWER, THE RESIDENT FELL OUT WHEN LOCKING NUT CAME OFF AND THE BOLT CAME LOOSE. LOCKING NUT WAS NOWHERE TO BE FOUND. THERE WERE NO INJURIES ACCORDING TO STAFF. THE PRODUCT HAS NOT BEEN TAKEN OUT OF USE;, CUSTOMER BOUGHT A BOLT AND 2 LOCKING NUTS TO FIX IT SINCE THIS WAS THEIR ONLY LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135000 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RPL600-2

    Patients

    Seq Age Sex Outcome Treatment
    1 32 Other