BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-SERIES PORTABLE SCALE ASSEMBLY

    MDR report key: 3830115 · Received May 8, 2014

    Report

    Report Number
    3007802293-2014-00011
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    November 26, 2013
    Report Date
    May 7, 2014
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE PICTURES AND IT APPEARS THAT THE SPLIT RING WAS OVERSTRETCHED POSSIBLY DURING A CEILING LIFT STRAP CHANGE. THE ROOT CAUSE APPEARS TO BE AN OVERSTRETCHED SPLIT RING POSSIBLY AFTER A STRAP CHANGE. WE WILL REISSUE A BULLETIN TO SHOW USERS THE CORRECT METHODS TO REMOVE/INSTALL THE SPLIT RING ON SCALES. ALSO INCLUDED IN THE BULLETIN WILL BE CORRECT AND INCORRECT PICTURES OF THE SPLIT RING. THE USER MANUAL FOR THE SCALE ASSEMBLY AND TECHNICAL MANUALS FOR THE CEILING LIFTS WILL BE REVISED TO INCLUDE ADD'L INFO.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE SPLIT RING LOCATED ON THE PIN THAT CONNECTS THE STRAP TO THE SCALE BROKE. THE PIN AND WASHER CAME OUT OF THE ASSEMBLY CAUSING THE PT IN THE SLING TO FALL INTO THE BATH TUB. THERE WERE NO INJURIES SUSTAINED AS THE TUB WAS FULL. THE SPLIT RING THAT FAILED WENT DOWN THE DRAIN WHEN THE STAFF DRAINED THE TUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278287 C-SERIES PORTABLE SCALE ASSEMBLY NONE FSA PRISM MEDICAL 370856

    Patients

    Seq Age Sex Outcome Treatment
    1