BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C450 MANUAL TRAVERSE

    MDR report key: 6258888 · Received January 17, 2017

    Report

    Report Number
    3007802293-2017-00083
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 17, 2017
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARRY BAR WAS RETURNED TO THE MANUFACTURER,TOLLOS WITH COMPLAINT RELATED INFO. THE PRISM C450 MANUAL TRAVERSE LIFT DID NOT FAIL TO MEET SPECIFICATIONS. ROOT CAUSE:USER ERROR BY NOT RELEASING THE PLUNGER TO LOCK THE TOLLOS CARRY BAR AFTER ROTATING IT. INCREASED LOAD ON THE MIDDLE BOLT CAUSED IT TO FRACTURE. NO ROOT CAUSE FOR LIFT, IT FUNCTIONED AS INTENDED. CORRECTIVE ACTION:RETRAIN STAFF ON PROPER USE OF THE CARRY BAR. NO CORRECTIVE ACTIONS FOR LIFT, IT FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 AN INCIDENT OCCURRED INVOLVING A A PRISM C450 MANUAL TRAVERSE LIFT WITH A TOLLOS CARRY BAR (NONPRISM PRODUCT) ATTACHED. DURING THE TRANSFER OF A RESIDENT THE SHACKLE ON THE TOLLOS CARRY BAR SEPARATED, CAUSING THE CARRY BAR HOLDING THE RESIDENT TO DETACH FROM THE LIFT. UNSPECIFIED INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40669 C450 MANUAL TRAVERSE C450 LIFT FSA PRISM MEDICAL 323100

    Patients

    Seq Age Sex Outcome Treatment
    1