BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M5

    MDR report key: 11837668 · Received May 17, 2021

    Report

    Report Number
    1221084-2021-00020
    Event Type
    Death
    Date Received
    May 17, 2021
    Date of Event
    March 9, 2021
    Report Date
    July 2, 2021
    Manufacturer
    PERMOBIL AB (PAB
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INSPECTED BY PERMOBIL TECHNICIANS WHO WERE UNABLE TO DETECT ANY KIND OF MALFUNCTION OR DEVIATION IN OPERATION HAVING OCCURRED WITH THE WHEELCHAIR, ONLY MINOR PHYSICAL DAMAGES THAT ARE BEING ATTRIBUTED TO THE IMPACT SUSTAINED DURING THE INCIDENT. THE ERROR LOG IN THE DRIVE ELECTRONICS WAS EVALUATED AND NOTHING WAS FOUND TO BE SEEN OUTSIDE OF NORMAL CONDITIONS. THE SERVICE PROVIDER REPORTS THE END-USER WAS DIAGNOSED AS SUFFERING FROM ATHETOID CEREBRAL PALSY WHICH HAS THE POTENTIAL TO CREATE INVOLUNTARY BODY MOVEMENTS, ESPECIALLY WHEN TRYING TO PERFORM ACTS OF FREE WILL. ROOT CAUSE FOR THIS INCIDENT IS NOT KNOWN, HOWEVER EVIDENCE POINTS TO A POSSIBLE USE ERROR SCENARIO, WHERE THE USER DRIVING THE WHEELCHAIR TOWARDS THE COMPUTER DESK IN A SPEED HIGH ENOUGH TO CAUSE IMPACT TO THE DESK RESULTING IN THE RIGHT ARMREST OF THE SEAT UNIT TO PUSH UPWARDS (WHERE JOYSTICK CONTROL IS ATTACHED). THIS WAS ALSO CONFIRMED TO BE THE FINAL RESTING POSITION OF THE WHEELCHAIR WHEN THE USER WAS DISCOVERED. IN THIS CASE PERMOBIL DETERMINED THAT THERE IS NO TECHNICAL MALFUNCTION TO THE PRODUCT THAT MIGHT HAVE CAUSED THE INCIDENT TO HAPPEN. THE ACTUAL ROOT CAUSE IS NOT POSSIBLE TO ESTABLISH AS THE ACTS PERFORMED BY THE USER CANNOT BE CONFIRMED, ONLY BE THE MOST PROBABLE CAUSE TO THE INCIDENT BASED ON THE FACTS RECEIVED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PERMOBIL HAS NOT BEEN ABLE TO REACH A DETERMINATION IF A DEVICE MALFUNCTION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PERMOBIL HAS BEEN UNABLE TO PERFORM ANY KIND OF INSPECTION OF THE WHEELCHAIR AT THIS EARLY STAGE BUT IS URGENTLY SEEKING ACCESS IN ORDER TO PERFORM A TECHNICAL EXAMINATION. AT THIS TIME, THE DEVICE IS BEING RETURNED TO PERMOBIL FRANCE TO UNDERGO A THOROUGH INSPECTION. UPON THE COMPLETION OF DEVICE EVALUATION, OR UPON THE RECEIPT OF ANY NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED REPORT OF THE END-USER BEING FOUND DECEASED AT HIS HOME BY AN ATTENDANT THAT HAD COME TO HIS HOME TO HELP HIM TO GO TO BED FOR THE NIGHT. REPORT INDICATED THE END-USER WAS FOUND SQUEEZED IN BETWEEN THE WHEELCHAIRS SEAT UNIT AND A COMPUTER DESK, WITH THE DESK REPORTEDLY PRESSING AGAINST THE END-USER'S DIAPHRAGM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731884 PERMOBIL M5 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB M5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death