BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED LANYARD 12" AND TP LIFT

    MDR report key: 3830124 · Received May 8, 2014

    Report

    Report Number
    3007802293-2014-00008
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    August 16, 2013
    Report Date
    May 7, 2014
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LINKAGE IN THE LANYARD SHOWED SIGNS OF DEFORMATION AND THERE WAS DAMAGE TO ONE OF THE THREADS. NO DAMAGED OBSERVED TO THE NUT AND INTERNAL THREADS IN THE LINK. PER THE SPECIFICATION SHEET OF THE LINK, THE BREAKING STRENGTH IS APPROXIMATELY 5 TIMES THE SAFE LOAD ((B)(4)). BASED ON OUR OBSERVATIONS WE CAN ATTRIBUTE THIS TYPE OF FAILURE TO: THE LOAD RATING WAS EXCEEDED RESULTING IN THE SLIPPAGE OF THE NUT AND DEFORMING THE LINK OR; 2) THE NUT WAS NOT CLOSED ALL THE WAY SO THAT NO THREADS WERE EXPOSED AND THE LINK FAILED. PRISM MEDICAL LTD. HAS REPLACED THE DAMAGED LANYARD WITH THE CURRENTLY IN STOCK MODEL OF THE LANYARD (WHICH DOES NOT USE A NUT/THREAD COMBINATION). ALSO THE FACILITY WAS RECOMMENDED TO CHECK THE LANYARDS IN USE TO ENSURE THAT THE LINKS ARE SECURED CORRECTLY.

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED AT (B)(6) WHERE THE D-LINK ON A 364681 LANYARD DEFORMED AND DROPPED A PATIENT ALONG WITH A TP LIFT (SERIAL NUMBER (B)(4)) WHICH WAS CONNECTED TO THE LANYARD. THE (B)(6) PATIENT INCURRED MINOR INJURIES THAT DID NOT REQUIRE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278254 FIXED LANYARD 12" AND TP LIFT NONE FSA PRISM MEDICAL 303000 AND 364681

    Patients

    Seq Age Sex Outcome Treatment
    1