BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE ZRA SERIES 2

    MDR report key: 2090004 · Received April 12, 2011

    Report

    Report Number
    3032618-2011-00001
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 8, 2011
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PARTS RETURNED TO US CONSISTED OF THE RIGHT AND LEFT BACKREST BRACKET ASSEMBLIES AND THE TITANIUM BACKREST. INSPECTION: BASED UPON VISUAL INSPECTION, IT IS APPARENT THAT THE BACKREST PIVOT STUD ON THE RIGHT SIDE BACKREST HINGE ASSEMBLY WAS BROKEN, THEREBY SEVERING THE CONNECTION BETWEEN THE BACK MOUNT BRACKET (WHICH IS ATTACHED TO THE SEAT TUBE OF THE WHEELCHAIR) AND THE BACKREST PIVOT ASSEMBLY (WHICH IS ATTACHED TO THE TITANIUM BACKREST). UPON FURTHER INSPECTION, IT WAS APPARENT THAT A ROUGH EDGE OF THE BROKEN BACKREST PIVOT STUD HAD WORN AWAY SIGNIFICANT AMOUNT OF MATERIAL FROM THE BACK MOUNT BRACKET, WITH MOST OF THE WEAR BEING IMMEDIATELY FORWARD AND AFT OF THE HOLE THROUGH WHICH THE BACKREST PIVOT STUD IS MOUNTED IN THE BACK MOUNT BRACKET. IN ADDITIONAL, THERE WAS A SIGNIFICANT AMOUNT OF SCRATCHING LOCATED ALL OVER THE UPPER PORTION OF THE BACK MOUNT BRACKET, HOWEVER, THIS SCRATCHING WAS NOT NEARLY AS EXTENSIVE AS THE WEAR THAT WAS APPARENT IMMEDIATELY FORWARD AND AFT OF THE AFOREMENTIONED HOLE. THE LOCK BLOCK ON THE RIGHT SIDE OF THE CHAIR (USED TO ADJUST THE ANGLE OF THE BACKREST) WAS SECURELY ATTACHED TO THE BACK MOUNT BRACKET, WITH NO EVIDENCE OF WEAR IN THE INTERLOCKING GROOVES ON THE BACK MOUNT BRACKET OR ON THE LOCK BLOCK. IN ADDITION, IT WAS VISUALLY NOTED THAT THE LEFT SIDE BACKREST HINGE ASSEMBLY WAS INTACT, WITH NO EVIDENCE OF DAMAGE TO THE BACKREST PIVOT STUD. HOWEVER, THE LOCK BLOCK WAS NOT SECURELY ATTACHED TO THE BACK MOUNT BRACKET AND THERE WAS EVIDENCE THAT THE LOCK BLOCK HAD GOUGED AWAY AS SIGNIFICANT AMOUNT OF MATERIAL COMPRISING THE INTERLOCKING GROOVES ON THE BACK MOUNT BRACKET. ANALYSIS: THE PT HAS STATED THAT, PRIOR TO THE ACCIDENT, THE PT EXPERIENCED EXCESSIVE PLAY IN THE BACKREST, WHICH PROMPTED HER TO CALL HER SERVICE PROVIDED TO SERVICE THE BACKREST. HOWEVER, THE PT ALSO STATED THAT SHE DID NOT PAY CLOSE ATTENTION TO WHAT WAS DONE TO THE WHEELCHAIR DURING THIS SERVICE CALL. IN LIGHT OF THIS FACT AND THE FOREGOING INSPECTION AND TESTING, WE CONCLUDE AS FOLLOWS: THE EXCESSIVE WEAR ON THE RIGHT BACK MOUNT BRACKET WAS CAUSED BY THE BROKEN BACKREST PIVOT STUD, INDICATING THAT THE PT CONTINUED TO USE THE WHEELCHAIR FOR A SIGNIFICANT AMOUNT OF TIME AFTER THE BACKREST PIVOT STUD FAILED. OUR TESTING CONFIRMED THAT THE WHEELCHAIR WAS STILL FUNCTIONAL WITH THIS BOLT MISSING, BUT THAT THERE WAS EXCESSIVE "PLAY" WHICH WOULD LIKELY TRIGGER, AND DID TRIGGER IN THIS CASE, A CALL TO THE SERVICE PROVIDER TO INSPECT THE PRODUCT SINCE IT SEEMS TO BE NOT FUNCTIONING PROPERLY. OUR TESTING SHOWED THAT THE INTERLOCKING GROOVES ON THE LOCK BLOCK AND THE BACK MOUNT BRACKET WERE STILL FUNCTIONAL WHEN THE LOCK BLOCK WAS REPOSITIONED AND REATTACHED PROPERLY TO THE BACK MOUNT BRACKET. THIS INDICATES THAT SOMEONE IMPROPERLY ADJUSTED THE LOCK BLOCK BY SECURING IT TO THE BACK MOUNT BRACKET WITHOUT PROPERLY ALIGNING THE INTERLOCKING GROVES. WHEN NOT PROPERLY ALIGNED, THE STEEL GROVES ON THE LOCK BLOCK COULD GOUGE THE ALUMINUM GROOVES ON THE BACK MOUNT. THE ACCIDENT OCCURRED AFTER THE SERVICE PROVIDER ATTEMPTED TO DIAGNOSE THE REASON FOR THE EXCESSIVE "PLAY" IN THE BACKREST. IN LIGHT OF THE FACT THAT THE PT WAS PERMITTED TO CONTINUE TO USE THE PRODUCT AFTER THIS SERVICE CALL, IT APPEARS LIKELY THAT THE SERVICE PROVIDER FAILED TO NOTICE THE BROKEN BACKREST PIVOT STUD. FURTHERMORE, GIVEN THE GOUGING CAUSED BY THE LOCK BLOCK ON THE LEFT SIDE BACK MOUNT BRACKET, IT SEEMS LIKELY THAT THE SERVICE PROVIDER COMPOUNDED THIS ERROR BY IMPROPERLY REPOSITIONING THE LOCK BLOCK WITH ITS INTERLOCKING GROOVES NOT FULLY ENGAGED IN THE INTERLOCKING GROOVES ON THE BACK MOUNT BRACKET. THIS CREATED A SITUATION THAT PERMITTED THE LOCK BLOCK TO WEAR AWAY THE GROOVES ON THE BACK MOUNT BRACKET, WHICH COULD HAVE RESULTED IN A SUDDEN CHANGE TO THE PT'S BACKREST ANGLE IN THE REARWARD DIRECTION. SINCE THE PT HAS LIMITED TRUNK CONTROL, THIS SUDDEN SHIFT OF CENTER OF GRAVITY COULD HAVE TRIGGERED THE BACKWARDS FALL FROM THE WHEELCHAIR. BASED ON THE FOREGOING EVIDENCE, OUR CONCLUSION IS THAT WHILE THE BACKREST PIVOT STUD FAILED PREMATURELY, THIS DID NOT DIRECTLY CAUSE THE ACCIDENT. AT MOST, THIS FAILURE TRIGGERED A SERIES OF EVENTS THAT CULMINATED IN HUMAN ERROR THAT DIRECTLY TRIGGERED THE ACCIDENT.

    Description of Event or Problem · 1

    IN A CONVERSATION WITH THE PT ON (B)(6) 2011, THE PT STATED THAT "PARTS FELL OFF HER WHEELCHAIR AND SHE FELL OUT BACKWARDS AND HIT HER HEAD SO HARD THAT SHE LOST A PERMANENT CROWN AND WAS HOSPITALIZED." PT STATED THAT SHE WAS NOW OUT OF THE HOSPITAL, BUT WAS EXPERIENCING SOME SHORT-TERM MEMORY LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TILITE ZRA SERIES 2 WHEELCHAIR, MECHANICAL IOR TISPORT, LLC ZRA SERIES 2

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization