BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 1880009 · Received October 19, 2010

    Report

    Report Number
    3003508375-2010-00004
    Event Type
    Other
    Date Received
    October 19, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 19, 2010
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE HOTLINE ATTEMPTED TO WORK WITH THE USER ON WAYS TO ADJUST THE LEGREST ASSEMBLIES AND REQUESTED TO SEND FIELD SERVICE TO INVESTIGATE, HOWEVER, USER WAS DOUBTFUL THAT THE COMPANY COULD BE OF ANY HELP. USER STATES THAT HE DEALS WITH A SEATING SPECIALIST WHO IS AN EXPERT IN THEIR PROFESSION AND STATES THIS INDIVIDUAL HAS ALREADY "INVESTIGATED" ALL ADJUSTMENT POSSIBILITIES. IN AN EFFORT TO BETTER UNDERSTAND THE REPORTED INJURY, THE COMPANY OBTAINED PRIOR PERMISSION FROM THE USER TO SPEAK WITH HIS SEATING SPECIALIST. FOLLOWING NUMEROUS ATTEMPTS TO CONTACT THE SPECIALIST, THE COMPANY SERVICE MGR SPOKE WITH HER ON (B)(4) 2010. SHE STATED THAT ALL SHE COULD TELL US WAS THAT THE USER DID NOT HAVE THE REPORTED SORES PRIOR TO THE CONVERSION. FURTHER INVESTIGATION BY THE COMPANY DETERMINED THAT AN ADJUSTMENT MECHANISM KNOWN AS THE "TUCK LINKAGE" MAY NOT HAVE BEEN ADJUSTED PROPERLY AFTER THE CONVERSION. THERE IS A TUCK LINKAGE MECHANISM ON BOTH THE LEFT AND RIGHT SIDE OF THE DEVICE TO HELP SET THE FORWARD ANGLE OF EACH LEGREST, WHICH COULD HELP RELIEVE ANY PRESSURE IN THE REPORTED INJURY SITE. IT WAS FURTHER DETERMINED THAT THE RIGHT SIDE TUCK LINKAGE WAS DAMAGED SOMETIME PRIOR TO THE LEGREST CONVERSION, WHICH WOULD HAVE PREVENTED THE PROPER ADJUSTMENT OF THE LEGREST ANGLE, POST CONVERSION. SERVICE TO REPLACE THE RIGHT SIDE TUCK LINKAGE WAS COMPLETED ON (B)(4) 2010. THE COMPANY SUSPECTS THAT INADEQUATE/IMPROPER ADJUSTMENT OF THE LEGRESTS POST CONVERSION MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE COMPANY WILL MONITOR AND F/U WITH THE USER ONCE SEATING/LEGREST ADJUSTMENTS HAVE BEEN MADE BY THE USER'S SEATING SPECIALIST TO DETERMINE IF THOSE ADJUSTMENTS HAVE ALLEVIATED THE REPORTED CONDITION.

    Description of Event or Problem · 1

    USER REPORTS THAT, TWO (2) WEEKS AFTER AN UPGRADE TO A FOLD FLAT SEATING DESIGN ON HIS LEGREST ASSEMBLIES IN (B)(6) 2010, HE DEVELOPED SORES ON BOTH ISCHIUMS ("SEAT BONE"). USER STATES THAT, IN (B)(6) 2010, THE SORE THAT WAS ON HIS RIGHT ISCHIUM REQUIRED SURGERY. USER STATES THAT HE CONVALESCED WELL AND WENT BACK TO USING HIS DEVICE IN (B)(6) 2010. USER STATES THAT HE HAS NOW DEVELOPED ANOTHER SORE IN HIS RIGHT ISCHIUM AREA THAT WILL NOW NEED SURGERY. USER STATES HE CONCLUDES THAT THE LEGREST CONVERSION LED TO THE SORES AROUND BOTH OF THE ISCHIUM AREA, WITH THE RIGHT SORE HAVING HAD SURGERY ONCE AND PROBABLY AGAIN NEEDING SURGERY. USER REQUESTED THAT HIS DEVICE BE CONVERTED BACK TO THE PREVIOUS CONFIGURATION OF LEGREST ASSEMBLY. THE COMPANY IS UNABLE TO FULFILL THAT REQUEST AS THE PARTS THAT WERE REMOVED DURING CONVERSION WERE SCRAPPED AND REPLACEMENT PARTS FROM THAT PRIOR DESIGN ARE NO LONGER AVAILABLE. THIS REPORT IS FILED AS AN ADVERSE EVENT MDR DUE TO THE REPORTED INJURY AND NO ALLEGATION/EVIDENCE OF PRODUCT MALFUNCTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. IBOT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R