BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 1070446 · Received July 3, 2008

    Report

    Report Number
    9617021-2008-00026
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 26, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY COULD NOT IDENTIFY THE EXACT LIFT OR SLING INVOLVED IN THE EVENT. ON-SITE EVALUATION OF THE LIFTS INDICATED THEY HAD MULTIPLE SCRATCHES AND PAINT PEELING. PICTURES SHOWED NO FUNCTIONAL DAMAGE TO THE LIFT; THE CLIP ATTACHMENT POINTS WERE SHOWN TO BE INTACT. FIFTEEN SLINGS WERE EVALUATED ON-SITE WITH NO SIGNIFICANT SHORTCOMINGS FOUND. KNOWLEDGE FROM PREVIOUS INCIDENT INVESTIGATION AND SIMULATION OF THIS TYPE OF EVENT HAVE SHOWN THAT IN NORMAL USE, ONCE ATTACHED TO THE LIFT, THE CLIP CANNOT DETACH, AND THAT A REPORTED DETACHMENT IS MORE LIKELY THAN NOT THE RESULT OF THE CLIP NOT BEING ATTACHED IN THE FIRST PLACE. THE GUIDELINES FOR USE THAT ARE SUPPLIED WITH EACH SLING WARN THAT THE CLIPS ARE TO BE VERIFIED TO BE ATTACHED AND THE STRAP OF THE SLING UNDER TENSION BEFORE LIFTING OF THE PT COMMENCES. BASED ON THE INFO RECEIVED AND PRODUCT KNOWLEDGE FROM PREVIOUSLY DOCUMENTED TESTS AND SIMULATIONS, THE MFR CONCLUDES THAT IN ALL LIKELINESS, THE CLIP WAS NOT PROPERLY ATTACHED BEFORE THE PT WAS LIFTED, WHICH CAUSED THE RESIDENT TO DROP OUT OF THE SLING LATER ON IN THE LIFTING CYCLE. FROM THE INFO AND THE INVESTIGATION, THE MFR CANNOT COME TO A CORRECTIVE ACTION TOWARDS THE PRODUCT, BUT WILL CONTINUE TO MONITOR COMPLAINT TRENDING AND EVALUATE INCIDENT REPORTING AS WELL AS THE LATEST STATE OF TECHNOLOGY TO POSSIBLY PERFORM A FOLLOW-UP ACTION IN THE FUTURE. THE MFR STRONGLY SUGGESTS THAT ALL STAFF AT THE FACILITY BE (RE) TRAINED IN ACCORDANCE WITH THE OPI OF THE LIFT AND THE GUIDELINES FOR USE OF THE SLING.

    Description of Event or Problem · 1

    THE FACILITY REPORTS AN UNK CAREGIVER WAS TRANSFERRING THE INJURED RESIDENT. THE SLING DETACHED, CAUSING THE RESIDENT TO HIT HIS HEAD ON THE JIB ASSEMBLY OF THE LIFT. THE PT WAS TAKEN TO THE ER. INJURIES AND TREATMENT WERE NOT SPECIFIED. THE FACILITY BELIEVES THE EVENT TO BE THE RESULT OF USER ERROR.

    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