BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 1221515 · Received November 5, 2008

    Report

    Report Number
    9617021-2008-00045
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    August 12, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFTER WAS INSPECTED ON-SITE AND WAS FOUND TO BE FUNCTIONING PER OEM SPECIFICATIONS WITH NO VISIBLE DAMAGE EVIDENT ON THE DEVICE. THE SLING INVOLVED WAS A SIZE LARGE, HAD NO SIGNS OF TEARS OR MODIFICATIONS, AND WAS IN OK CONDITION, BASED ON PICTURES SENT TO THE MANUFACTURER. IT WAS INDICATED THE RIGHT LEG CLIP BECAME DETACHED. THE RESIDENT IS INDICATED BY THE CUSTOMER NOT TO HAVE BEEN PRONE TO UNCONTROLLED MOVEMENT. NO SUCH MOVEMENT OR SPASM IS INDICATED TO HAVE TAKEN PLACE AT THE TIME OF THE INCIDENT. NO TRAINING DATE WAS RECEIVED FOR THE CAREGIVER OPERATING THE LIFTER. BOTH THE LIFT'S OPI AS WELL AS THE SLING'S GUIDELINES FOR USE CLEARLY STATE THAT, BEFORE LIFTING THE RESIDENT, THE CLIPS SHALL BE PUT IN PLACE AND THE CLIPS AND STRAPS UNDER TENSION. FROM INTERNAL INVESTIGATION REPORTS BY MANUFACTURING SIMULATING CLIP DETACHMENTS, IT HAS BEEN ESTABLISHED THAT CLIPS CANNOT BECOME UNDONE FROM THE HANGER BAR ONCE PUT IN PLACE AND CHECKED TO BE UNDER TENSION BEFORE LIFTING THE RESIDENT, EXCEPT FOR THE CAREGIVER MANUALLY DETACHING THE CLIP. THERE IS AN EXCEPTION TO THIS RULE, NAMELY THAT IT IS IMPROBABLE BUT POSSIBLE THAT A LEG CLIP CAN COME OFF WHEN KICKED UP BY THE RESIDENT'S KNEE FROM A POSITION BETWEEN FULLY HORIZONTAL AND FULLY SEATED. FOR THIS TO HAPPEN, THE KNEE MUST BE UNDER THE CLIP AND MOVED INWARD AND VIOLENTLY UPWARD DURING AN INVOLUNTARY MOVEMENT, SUCH AS COMBATIVENESS, SPASMS, OR CONVULSIONS. NO SUCH MOVEMENT WAS INDICATED TO HAVE TAKEN PLACE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION AND EVALUATION DONE, THE MANUFACTURER CONCLUDES THE RESIDENT DID NOT DROP OUT OF THE SLING AS A RESULT OF CLIP DETACHMENT, BUT RATHER FROM NON-ATTACHMENT, MEANING USER ERROR. A CAPA HAS BEEN INITIATED TO IMPROVE AWARENESS OF THIS ISSUE WITH DEVICE OPERATORS AND TO REMIND THEM OF THE OPI AND GUIDELINES.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE PATIENT HAD BEEN LOADED UP INTO THE SLING FOLLOWING A BATH. THE CAREGIVER LIFTED THE RESIDENT OFF THE SHOWER TROLLEY AND PROCEEDED TO PULL THE RESIDENT OUT OF THE SPA AREA. AT THIS TIME, THE RIGHT FRONT CLIP ON THE SLING ATTACHMENT CAME UNFASTENED AND THE RESIDENT SLIPPED OUT THE FRONT OF THE SLING, FALLING TO THE GROUND. THE RESIDENT SUSTAINED A MODERATE-SIZED BUMP ON THE BACK OF THE HEAD AND SOME BRUISING. NO OTHER INJURIES OR TREATMENT INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO PATIENT LIFT FNG ARJO MED. AB LTD. KPBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR