BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    323117

    MDR report key: 7111037 · Received December 12, 2017

    Report

    Report Number
    3007802293-2017-00018
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 12, 2017
    Manufacturer
    HANDICARE USA
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT, WAS RETURNED TO HANDICARE FOR INVESTIGATION. UPON DISASSEMBLY, THE TAPE GEAR WAS REMOVED AND FOUND TO HAVE BOTH STRAP GUIDES (635125) DEFORMED. THE INSIDE DIAMETERS WERE DEFORMED. OUTSIDE DIAMETER DEFORMATION WAS ONLY EVIDENT ON THE GEAR-SIDE STRAP GUARD. THIS SUGGESTS THAT THE STRAP MIGRATED OVER THE STRAP GUIDE ON THE GEAR SIDE. EVIDENCE OF STRAP FRAYING ALONG THE SAME SIDE, MOST LIKELY CAUSED BY MIGRATION OVER THE GEAR MESH, FURTHER POINTS TO STRAP MIGRATION. THE REMAINING STRAP WAS BOUND TIGHTLY TO HUB (635026). THE REMAINING STRAP WAS REMOVED. CUTS WERE FOUND IN TWO PLACES - AT THE STRAP LOOP AND IMMEDIATELY ABOVE THE END OF THE STRAP FOLD. INTERNAL TESTING ON SHARP HUBS (T2017-13) SHOWED VERY SIMILAR RESULTS, WHICH CUTS AT THE SAME LOCATIONS AFTER 1639 CYCLES AT 625 LB. THE ROOT CAUSE FOR THESE FAILURES WAS FOUND TO BE A SHARP EDGE AT THE INSIDE RADIUS OF THE HUB SLOT. RECALL FSN-0016U INITIATED NOVEMBER 10, 2017 ADDRESSED THE REPLACEMENT OF THESE UNITS. AS THIS FAILURE WAS WITNESSED WITH FOUR RECORDED LIFT CYCLES PER THE INTERNAL LIFT COUNTER, ANOTHER FACTOR ALSO CONTRIBUTED. THE PREVAILING THEORY IS THAT SLACK WAS INTRODUCED AS THE STRAP WAS COMPLETELY LOWERED FROM THE UNIT, ALLOWING THE STRAP TO MIGRATE TO THE GEAR MESH. THE TENSION IN THE STRAP GENERATED FROM BEING CAUGHT IN THE GEAR MESH WOULD HAVE PULLED THE STRAP BEYOND ITS DESIGNED SPECIFICATION, ALONG A SHARP EDGE, RESULTING IN THE CUTS WITNESSED. HOW THE SLACK WAS INTRODUCED IS UNKNOWN, AND WAS ATTEMPTED TO BE RECREATED VIA INTERNAL TESTING. TEST T2017-23 WAS SETUP, WITH NEW STRAP AND ORIGINAL PARTS, TO CYCLE ALONG THE MIDDLE 20" OF THE LIFTING RANGE (31" TO 51" OF STRAP RELEASED) AT 625 LB. THE 273 LB CYCLES WERE COMPLETED WITH NO SIGNS OF UNEXPECTED STRAP WEAR. THIS FURTHER SUPPORTS THAT THE SHARP HUB ALONE DID NOT CONTRIBUTE TO THIS FAILURE. FURTHER TESTING WAS PERFORMED TO SIMULATE STRAP SLACK BEING INTRODUCED. THE ONLY SUCCESSFUL ATTEMPT WAS BY MANUALLY FORCING THE STRAP INTO THE GEAR MESH. THE ROOT CAUSE FOR SLACK INTRODUCTION AT THIS POINT IS UNVERIFIED. THIS STRAP BREAKAGE DOES NOT POSE A HIGH RISK OF SUDDENLY DROPPING A PATIENT. AS THE STRAP IS TIGHTLY BOUND TO THE HUB, THE STRAP DOES NOT GET RELEASED FROM THE HUB UNTIL THE STRAP IS COMPLETELY LOWERED. ADDITIONALLY, THERE HAVE BEEN NO OTHER COMPLAINT RECORDS OF PREMATURE STRAP WEAR OR BREAKAGE AT THE HUB SLOT. DUE TO THIS, THERE IS A MINIMAL SAFETY RISK.

    Description of Event or Problem · 1

    A HANDICARE CLINICAL TRAINER WAS LOWERING THE STRAP WITH A CARRYBAR ATTACHED, FROM A C625 MANUAL TRAVERSE. THE STRAP AND CARRYBAR FELL TO THE FLOOR. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888655 323117 C625 MANUAL TRAVERSE FSA HANDICARE USA 323117

    Patients

    Seq Age Sex Outcome Treatment
    1