BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C300

    MDR report key: 7371784 · Received March 26, 2018

    Report

    Report Number
    1221084-2018-00018
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    February 24, 2018
    Report Date
    March 26, 2018
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE IS CONTRIBUTED TO A "COMPONENT FAILURE" LINKED TO A MOTOR VEHICLE ACCIDENT (MVA) WHICH OCCURRED IN (B)(6) 2017. THE PATIENT WAS OCCUPYING THE WHEELCHAIR WHEN THE SEAT DETACHED FROM THE CHASSIS, NO INJURIES WERE SUSTAINED. PHOTO EVIDENCE WAS SUPPLIED TO PERMOBIL TO CONFIRM COMPLAINT. THE PATIENT'S HUSBAND INFORMED PERMOBIL THAT THE SUSPECT WHEELCHAIR WAS INVOLVED IN AN UNREPORTED MVA AND ALLEGED THAT THE FAILURE OF THE FIXED SEAT TUBE (FST) TOP PLATE WAS CONNECTED TO THAT EVENT. THE PATIENT'S HUSBAND REPORTED THAT THE "FST" WAS NEVER REPLACED BY THE DEALER AFTER THE MVA. RECORDS SHOW THAT IN (B)(6) 2017 SEVERAL SPARE PARTS WERE QUOTED TO THE DEALER IN AN EFFORT TO REPAIR THE DEVICE. IN (B)(6) 2017, THE WHEELCHAIR WAS SCHEDULED FOR REPAIR AND THE DEALER PERFORMED A SECOND ASSESSMENT NOTING THAT THE "FST" LOWER MOUNTING PLATE HAD FRACTURED AND WAS SUBJECT TO FAILURE. PERMOBIL HAVING NOT BEEN MADE AWARE THAT THE PRODUCT WAS PREVIOUSLY INVOLVED IN A MVA SUPPLIED THE DEALER WITH A SECOND SPARE PARTS QUOTE TO REPLACE THE COMPROMISED FST. AT THIS TIME, THE SUSPECT COMPONENT WAS ON BACKORDER AND THE PARTS ORDER COULD NOT BE FULFILLED. THE SERVICING DEALER LATER CANCELLED THE PARTS ORDER FOR A REPLACEMENT FST AND INFORMED PERMOBIL THAT THE SUSPECT WHEELCHAIR WOULD BE SCRAPPED, AND THAT A NEW WHEELCHAIR WOULD BE PROVIDED TO THE PATIENT. PERMOBIL INFORMED THE PATIENT'S HUSBAND THAT OUR RECORDS INDICATED THAT THE DEVICE WAS NO LONGER IN USE AFTER (B)(6) 2017 AND THE WHEELCHAIR WOULD BE DISCARDED. THE PATIENT'S HUSBAND STATED THAT THE SERVICING DEALER NEVER COMMUNICATED THIS TO HIM OR THE PATIENT HENCE THEY CONTINUED TO USE THE DEFECTIVE WHEELCHAIR. THE PATIENT HAS BEEN INFORMED OF PERMOBIL'S ACCIDENT POLICY, IN THAT WE ARE UNABLE TO GUARANTEE THE CONTINUED PERFORMANCE OR SAFETY OF OUR PRODUCTS THAT HAVE BEEN INVOLVED IN MVA. SUCH EXTRAORDINARY EVENTS TO A SOPHISTICATED MEDICAL DEVICE MAY CREATE CONSIDERABLE DAMAGE THAT MAY BE IMPERCEPTIBLE TO AN INSPECTION AND ANY DAMAGE CAUSED BY THESE TYPES OF EVENTS EXCEED THE LIMITATIONS COVERED BY THE MANUFACTURER'S WARRANTY. PERMOBIL CONTACTED THE SERVICING DEALER IN AN ATTEMPT TO UNDERSTAND WHY THE MVA WAS NOT REPORTED TO PERMOBIL AND WHY/HOW THE DEVICE WAS APPROVED FOR CONTINUED USAGE WITH A COMPROMISED FIXED SEAT TUBE. THE SERVICE MANAGER REPORTED HAVING HAD SEVERAL DISCUSSIONS WITH THE PATIENT'S HUSBAND ABOUT WHEELCHAIR REPAIRS AND NOTHING WAS MENTIONED ABOUT THE DEVICE SUSTAINING DAMAGES FROM A MVA. IT WAS LATER DISCOVERED THAT THE PERSONNEL RESPONSIBLE FOR COORDINATING SCHEDULING ACTIVITIES WAS INFORMED OF THE INCIDENT INVOLVING A MVA, BUT NEVER COMMUNICATED THIS EVENT TO THE SERVICE MANAGER NOR WAS THIS DOCUMENTED IN THE PATIENT'S FILE. THE ACTING MANAGER INFORMED PERMOBIL THAT A MISCOMMUNICATION HAS TRANSPIRED BETWEEN DEPARTMENTS AND TRAINING WILL BE PERFORMED FOR ALL STAFF TO PREVENT REOCCURRING; AND THAT ALL FUTURE INCIDENT'S INVOLVING PERMOBIL POWER WHEELCHAIRS WILL BE COMMUNICATED TO PERMOBIL IMMEDIATELY AFTER THEY ARE MADE AWARE. THE DEALERSHIP WAS ALSO SUPPLIED OUR ACCIDENT POLICY AND CONFIRMED THAT THE PATIENT HAS BEEN APPROVED FOR A NEW WHEELCHAIR AND THE SUSPECT WHEELCHAIR WILL NO LONGER BE USED. THE DHR FOR THIS DEVICE WAS REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION. NOTE: THIS FAILURE IS CONSIDERED TO HAVE OCCURRED DUE TO A MVA. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION (CAPA (B)(4)) HAS BEEN IMPLEMENTED TO INVESTIGATE TOP PLATE FAILURES FROM WHICH HAVE BEEN ATTRIBUTED TO STRESSES BEING APPLIED OVER TIME LEADING TO EVENTUAL MATERIAL FATIGUE. THEREFORE, A NEW DESIGN HAS BEEN INTRODUCED TO IMPROVE THE OVERALL STRENGTH OF THE COMPONENT. NOTE: THE SUSPECT WHEELCHAIR HAS SURPASSED EXPECTED LIFE FOR THE DEVICE BY 2 YEARS.

    Description of Event or Problem · 1

    THE HUSBAND OF THE PATIENT REPORTED THE TOP PLATE ON THE FIXED SEAT TUBE BROKE AND CAUSED THE SEAT TO DETACH WHILE THE PATIENT WAS OCCUPYING THE WHEELCHAIR. THE PATIENT WAS NOT INJURED IN THIS EVENT. THE HUSBAND ALSO REPORTED THAT THE WHEELCHAIR WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT LAST YEAR AND BELIEVES THIS FAILURE MODE IS MOST LIKELY DUE TO THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212291 PERMOBIL C300 POWERED WHEELCHAIR ITI PERMOBIL INC. C300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1