BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXELSIOR

    MDR report key: 1748138 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00044
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHOTOS OF THE LIFT OR SLING HAVE BEEN PASSED TO MEDIBO FOR EXAMINATION, DURING OR BEFORE THE INVESTIGATION. NOTHING CAME BACK. THE DEVICE HISTORY RECORD SHOWS THAT THE EXCELSIOR WAS PRODUCED AND TESTED AT MEDIBO IN 06/2004. A REVIEW SHOWS THAT THERE WERE NO DEFECTS TO THE HOIST OR SLING. THE EXCELSIOR HAS BEEN USED AFTER THE INCIDENT. DURING A STIMULATION OF THE DESCRIBED EVENT WE FOUND THAT: THE TRAMPING AND THE SUBSEQUENT "EJECTION" OF THE CLIENT'S LEGS IS NOT NORMAL BEHAVIOR IN THIS SITUATION AND IS NOT CAUSED/FACILITATED BY THE LIFT OR THE SLING. EVEN WITH THE "EJECTION" OF THE LEGS AS DESCRIBED AND BEING FULLY CAUGHT BY A PROPERLY FITTED SLING, IT IS NOT POSSIBLE FOR BOTH THE CLIENT'S SHOULDERS TO DISLOCATE AND THE HIP TO BREAK. THIS WOULD, IN OUR OPINION, ONLY BE POSSIBLE IF THE CLIENT SUFFERS OF A CONDITION THAT MAKES THE MUSCLES, TENDONS AND/OR BONES FRAGILE WHEN EXTREME MOVEMENTS OR CONVULSIONS TAKE PLACE, OR WITH A COMBINATION OF THESE FACTORS. NONE OF THESE FACTORS WERE MENTIONED IN THE REPORT. THE EXCELSIOR MANUAL, WHICH WAS AVAILABLE TO THE USER ACCORDING TO THE REPORT, CLEARLY STATES: "ALWAYS USE THE CORRECT LIFTING EQUIPMENT. MAKE SURE THAT THE UNITS BEING USED ARE ADJUSTED TO THE PT AND THE SITUATION. ALSO IT SAYS TO "MAKE SURE THAT THE LOWER LEGS ARE ADEQUATELY SUPPORTED BY THE LOWER LEG SUPPORT". THE LAST DATE OF STAFF TRAINING COINCIDES WITH THE DATE OF THE INCIDENT. THE INDICATION THAT THE CARER SUSTAINED BRUISES WHILE SUPPORTING THE CLIENT - POINTING TO A SUDDEN AND POWERFUL IMPACT - DOES NOT SEEM TO CORRESPOND WITH THE STATEMENT THAT THE CLIENT, AFTER BEING CAUGHT BY THE SLING, WAS GENTLY GUIDED TO THE GROUND BY THE CAREGIVER. THE COMPLAINT HISTORY TELLS US THAT THIS IS THE FIRST DOCUMENTED COMPLAINT WITH THIS SPECIFIC PROBLEM WITH AN EXELSIOR. FROM THE INFO RECEIVED AND THE INVESTIGATION PERFORMED, MEDIBO CONCLUDES THAT: THERE IS NO DEFECT TO SLING OR HOIST THAT CAUSED THE INCIDENT OR PLAYED A SIGNIFICANT ROLE IN CAUSING THE INCIDENT, ACCORDING TO THE INCIDENT REPORT. THE DESCRIBED COMPLAINT IS NOT A SIGNIFICANT TREND FOR THIS PRODUCT. AS THERE HAVE BEEN NO PRIOR, SIMILAR COMPLAINTS; AND THIS FOR MORE THAN (B)(4) SIMILAR APPLIANCES IN THE MARKET, THAT SUCCESSFULLY PERFORM MULTIPLE LIFTING CYCLES DAILY; THIS POINTS OUT THAT THE CAUSE OF THE INCIDENT IS NOT DUE TO A CONSTRUCTION OR DESIGN ERROR. THIS WOULD OTHERWISE HAVE BECOME CLEAR BY FORMING A SIGNIFICANT COMPLAINT TREND. FROM A SIMULATION OF THE INCIDENT, FOLLOWING THE DESCRIPTIONS IN THE RECEIVED INCIDENT RAPPORT WE STRONGLY SUSPECT THAT THE PT HAS BEEN WRONGLY EVALUATED AS BEING SUITED FOR LIFTING WITH AN ACTIVE HOIST. THIS FOR BOTH THE MENTAL (LEGS TRAMPLING) AND PHYSICAL CONDITION (DISLOCATED ARMS AND BROKEN HIP) OF THE CLIENT. WITH THE INFO RECEIVED MEDIBO COMES TO THE CONCLUSION THAT THE CAUSE OF THE INCIDENT IS NOT CAREFULLY FOLLOWING AND APPLYING THE INSTRUCTIONS IN THE MANUAL WITH RESPECT TO THE EVALUATION OF WHICH LIFTING DEVICE TO USE FOR LIFTING THE PT. MEDIBO STRONGLY RECOMMENDS (RE)TRAINING OF THE CARERS WORKING WITH HOISTS WITH RESPECT TO THE MANUALS OF THE PRODUCTS INVOLVED.

    Description of Event or Problem · 1

    CLIENT IS A (B)(6) WOMAN OF (B)(6), STANDING ON AN ACTIVE HOIST IN A MOIST TOILET SPACE OF 225CM BY 225CM. CLIENT HAD A BRACE FOR LATERAL FLEXION, AND REPORTEDLY STARTED TRAMPLING ON THE FOOT REST. ACCORDING TO THE REPORT THE FOLLOWING ACTIONS TOOK PLACE IN THE GIVEN ORDER: RIGHT LEG SLIPPED OF FOOT REST DURING TRANSFER; RIGHT LEG CAME BEHIND LEFT LEG; CLIENT LET GO OF HAND GRIPS; LEFT LEG SLIPPED OFF FOOT REST; CLIENT WAS CAUGHT BY THE SLING. THIS WAS FOLLOWED BY CARERS GENTLY GUIDING THE CLIENT TO THE FLOOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELSIOR LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V. TES.408

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other