BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C300

    MDR report key: 6956567 · Received October 17, 2017

    Report

    Report Number
    1221084-2017-00088
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    August 7, 2017
    Report Date
    December 13, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE CANNOT BE DETERMINED. INFORMATION RECEIVED INITIALLY WAS THAT THE PATIENT CAME INDOORS TO CHARGE THE BATTERIES IN THE WHEELCHAIR AND AFTER 10 MINUTES A THERMAL INCIDENT HAD OCCURRED. LATER REPORTS WERE THAT THE WHEELCHAIR WAS LEFT ALONE IN A ROOM WITH THE BATTERY CHARGER TURNED ON AND CONNECTED TO THE WHEELCHAIR FOR OVER 2 DAYS. THE PATIENT'S BOTHER AFTER BECOMING AWARE OF THE THERMAL INCIDENT HAD OCCURRED TRIED TO COVER THE HEAT SOURCE WITH A PIECE OF FABRIC MATERIAL. WHEN THE THERMAL EVENT CONTINUED TO ESCALATE A WATER HOSE WAS THEN USED TO SPRAY DOWN THE WHEELCHAIR. THE TEST RESULTS FROM EXAMINATION OF THE WHEELCHAIR AND AFFECTED COMPONENTS DOES NOT GIVE A CLEAR ANSWER AS TO HOW THE EVENT BEGAN NOR THE ROOT CAUSE OF IT. ONLY PORTIONS OF THE BATTERY CHARGER CAME IN DIRECT CONTACT WITH THE HEAT SOURCE AND THE DAMAGE ONLY AFFECTED 16-INCHES OF CABLE CLOSEST TO THE CHARGER CORD PLUG. THERE IS NO DAMAGE TO THE REST OF THE CHARGER CORD, WHICH INDICATES THAT THE CURRENT FLOW THROUGH THE CHARGER CORD WAS NOT HIGH ENOUGH TO MELT THE INSULATION. IN ADDITION, THE 15A FUSE IN THE CHARGER WAS FOUND INTACT SHOWING THAT CURRENT COULD NOT HAVE EXCEED 15 AMPS FOR MORE THAN A VERY SHORT TIME. AFTER REMOVING THE CHARGER PLUG FROM THE JOYSTICK CHARGING SOCKET, THERE WAS NO INTERNAL EVIDENCE INDICATING THAT A BAD CHARGER CONNECTION IS THE CAUSE. WHEN INSPECTING THE JOYSTICK CONTROL CABLE INSTALLED ON THE WHEELCHAIR WE HAVE REASON TO BELIEVE THAT THE JOYSTICK CONTROLLER SUSTAINED DAMAGE FROM IMPACT TO AN EXTERNAL OBSTACLE, BECAUSE THE JOYSTICK MOUNTING BRACKET WAS BENT UPWARDS AND A PORTION OF THE JOYSTICK CABLE UNDERNEATH THE MOUNTING BRACKET SUSTAINED THE MOST DAMAGE FROM THE HEAT SOURCE. THIS IMPACT MAY HAVE CAUSED A SHORT CIRCUIT WHICH COULD HAVE INITIATED THE THERMAL INCIDENT. ACCORDING TO TESTING PERFORMED AT PERMOBIL, IT IS VERY UNLIKELY THAT THE SHORT CIRCUIT ALONE DEVELOPED INTO THE FULL THERMAL EVENT. THE SUSPECT CABLE IS MADE FROM STANDARD PVC AND BY ITS VERY NATURE IS SELF-EXTINGUISHING. IT IS CONSTRUCTED TO BE COMPLIANT ACCORDING TO (B)(4) WHICH MANDATES THE CABLE BE FLAME RETARDANT (UL 94, FLAMMABILITY STANDARD RATING, CLASSIFICATION V-0). IN CONCLUSION, THE FABRIC MATERIAL THROWN ON TOP OF THE JOYSTICK CONTROLLER MOST LIKELY ACCELERATED THE THERMAL INCIDENT AND HEAT SOURCE SPREAD TO THE REST OF THE WHEELCHAIR. ALL DAMAGED OR DEFECTIVE ITEMS ON THE WHEELCHAIR HAVE BEEN IDENTIFIED AND THE OPTION TO REPAIR THE DEVICE WAS GIVEN TO THE DEALER. THE WHEELCHAIR WILL MOST LIKELY BE REPLACED AND NOT REPAIRED BUT THE DECISION WILL BE LEFT IN BETWEEN THE FAMILY AND THE SERVICING DEALER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS AND ROOT CAUSE IS YET TO BE DETERMINED. IT WAS REPORTED THAT THE PATIENT HAD COME INDOORS TO CHARGE THE WHEELCHAIR'S BATTERIES AND WITHIN 10MIN A THERMAL INCIDENT OCCURRED. NO INJURIES REPORTED TO HAVE OCCURRED. THE WHEELCHAIR AND AFFECTED COMPONENTS ARE CURRENTLY UNDER EXAMINATION. PROBABLE CAUSE COULD BE THAT THE JOYSTICK MAY HAVE BEEN COMPROMISED PRIOR TO THE EVENT LEAVING THE INTERNAL JOYSTICK ELECTRONICS EXPOSED TO MOISTURE OR THE DAMAGE MAY BE RELATED TO A PINCHED CABLE. WE ARE STILL COLLECTING INFORMATION AND CONDUCTING FAILURE ANALYSIS. A FOLLOW UP MDR WILL BE SUBMITTED FOLLOWING THE CONCLUSION OF THIS INCIDENT. ANY MISSING INFORMATION NOT INCLUDED IN THIS REPORT WILL BE ADDED IN FINAL SUBMISSION.

    Description of Event or Problem · 1

    REPORTS ARE THAT A THERMAL INCIDENT OCCURRED WHILE THE WHEELCHAIRS BATTERIES WERE BEING CHARGED WHICH DAMAGED THE BATTERY CHARGER AND THE JOYSTICK CONTROLLER. THE PATIENT DID NOT GET INJURED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736315 PERMOBIL C300 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1