BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M300

    MDR report key: 5445927 · Received February 18, 2016

    Report

    Report Number
    1221084-2016-00005
    Event Type
    Death
    Date Received
    February 18, 2016
    Date of Event
    January 11, 2016
    Report Date
    May 16, 2018
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K103477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS INCOMPLETE AND ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE FACTS SURROUNDING THIS FAILURE MODE ARE NOT CLEAR AND FROM OUR INITIAL EVALUATION OF THE PRODUCT THE DEVICE IS NOT RESPONSIBLE FOR THIS INCIDENT. THE WHEELCHAIR WAS FOUND IN AN OPERATIONAL CONDITION WITHOUT ANY DISTURBANCES TO THE ELECTRONICS. HOWEVER, THE DEVICE DID SUFFER SOME EXTERIOR / SURFACE DAMAGE FROM HEAT EXPOSURE (SEE PICTURES OF DAMAGES; THE CITY OF (B)(6), DEPARTMENT OF OPEN RECORDS RECEIVED A REQUEST FROM PERMOBIL TO OBTAIN A COPY OF THE INVESTIGATION REPORT #(B)(4) AND THE FIRE INCIDENT REPORT #(B)(4). THE CITY OF (B)(6) "RIGHT-TO-KNOW" LAW PERMITS THE CITY 30 DAYS TO PROVIDE A FINAL RESPONSE. PERMOBIL'S INVESTIGATION OF THIS FAILURE WILL BE PLACED ON-HOLD UNTIL THESE DOCUMENTS CAN BE VIEWED. A FOLLOW UP MDR WILL BE FILED TO SUPPLY ANY MISSING INFORMATION NOT SUBMITTED IN THIS REPORT. THE DHR WAS REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ON-GOING, BUT NEW INFORMATION HAS SURFACED THAT PRESENTS STRONG ARGUMENT THAT THE WHEELCHAIR IS NOT THE CAUSE OF THE THERMAL EVENT FROM WHICH THE PATIENT HAD SUFFERED. ON MAY 2ND, OUR OUTSIDE COUNSEL REPORTED COMPLETING A THOROUGH REVIEW OF THE POLICE INVESTIGATION REPORT THAT WAS JUST OBTAINED. INVESTIGATORS FOUND EVIDENCE OF BURNED CLOTHING ON THE STOVE THAT MATCHED THE CLOTHING WORN BY THE PATIENT. THE INVESTIGATOR NOTED THAT THE PATIENT'S BROTHER (WHO OWNS THE HOME), INDICATED THAT THE PATIENT COULDN'T REACH THE STOVE CONTROLS. THE BROTHER LATER CONFIRMED THAT THE PATIENT COULD BE SOMEWHAT SNEAKY AND MAY HAVE USED THE STOVE. THE PATIENT'S BROTHER CONFIRMED THAT THE PATIENT COULD REACH THE SINK AND FAUCET. THIS RECOUNTS THE INVESTIGATORS DISCUSSION WITH THE FIRST RESPONDERS, WHO HEARD THE PATIENT TELL THEM (THOUGH MUFFLED, APPARENTLY) THAT THE STOVE CAUGHT HIM ON FIRE. FURTHER INVESTIGATION INTO THE FIRST RESPONDERS CLAIM WILL BE PURSUED. ALTHOUGH ROOT CAUSE SEEMS APPARENT BASED UPON ALL THE INFORMATION COLLECTED IN THIS INVESTIGATION. THE OPPOSING SIDE WILL CONTINUE THE ATTEMPT TO ASSOCIATE THIS DEVICE WITH THIS FAILURE MODE. THEREFORE, UNTIL THE CASE IS SETTLED THE ROOT CAUSE WILL REMAIN "UNKNOWN". IF ANY NEW INFORMATION IS RECEIVED THAT BRINGS THIS CASE CLOSER TO BEING RESOLVED, A FOLLOW-UP REPORT WILL BE SUBMITTED AND WILL INCLUDE ANY INFORMATION NOT PREVIOUS REPORTED. THE DHR FOR THIS DEVICE WAS REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL WAS ALERTED THAT THE PATIENT DIED DUE TO A THERMAL INCIDENT WHILE OCCUPYING THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101056 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death