BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QRS CARRY BAR

    MDR report key: 5502552 · Received March 15, 2016

    Report

    Report Number
    3007802293-2016-00052
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 19, 2016
    Report Date
    March 15, 2016
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY TECHNICIAN REASSEMBLED THE CARRY BAR AND SENT IT TO PRISM FOR INVESTIGATION. IT WAS RECEIVED ON FEB 25, 2016. THE PRISM TECHNICAL MARKETING MANAGER, INSPECTED THE CARRY BAR AND DID NOT SEE ANY EVIDENCE OF LOCTITE. THIS FLOOR LIFT WAS SOLD MARCH 7, 2014. THE CARRY BAR, 360758, SHOULD BE ASSEMBLED PER WI-A116 (REV A AT TIME OF MANUFACTURE). THE WORK INSTRUCTIONS STATE TO APPLY RED LOCTITE INTO THE HOLES IN WHICH THESE SCREWS MATE. THOUGH LOCTITE WAS NOT APPLIED, THE SPLIT LOCK WASHER FUNCTIONS TO MITIGATE THE LIKELIHOOD OF THE SCREW LOOSENING WITH TIME. THERE HAVE BEEN REPORTS OF CUSTOMERS LOOSENING THESE SCREWS, FALSELY BELIEVING IT IS NECESSARY IN ORDER TO CHANGE OR REMOVE THE CARRY BAR. WE THEREFORE THINK THESE SCREWS WERE LOOSENED BY THE USER, ALLOWING THE CARRY BAR TO SEPARATE. WHILE THE LIFT WAS INSPECTED (RH, MARCH 5, 2014), THE CARRY BAR IS NOT INCLUDED IN THIS CERTIFICATE OR INSPECTION PROCEDURE. IT IS ASSEMBLED SEPARATELY TO THE FLOOR LIFT ASSEMBLY PROCESS. IN 2015, QUALITY HAS STARTED DOING RANDOM INSPECTIONS OF CARRY BARS. IN ADDITION, ASSEMBLY WAS REMINDED OF THE NECESSITY OF LOCTITE IN ALL CARRY BAR ASSEMBLIES AND A NOTICE WAS POSTED ON MARCH 7, 2016.

    Description of Event or Problem · 1

    AN EMPTY SLING WAS HANGING ON THE QRS CARRY BAR (360758) AND WHEN THE FLOOR LIFT, IT WAS ATTACHED TO WAS BEING MOVED, THE CARRY BAR FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155924 QRS CARRY BAR QRS CARRY BAR FSA PRISM MEDICAL 360758

    Patients

    Seq Age Sex Outcome Treatment
    1