BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C400

    MDR report key: 7097994 · Received December 7, 2017

    Report

    Report Number
    1221084-2017-00097
    Event Type
    Death
    Date Received
    December 7, 2017
    Date of Event
    August 6, 2017
    Report Date
    December 7, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE IS "UNKNOWN". IT WAS REPORTED THAT THE PATIENT WAS USING THE WHEELCHAIR TRAVELING DOWNHILL ON WET CONCRETE. THE PATIENT HAVING RELEASED THE JOYSTICK CAUSED THE WHEELCHAIR TO STOP, SLIDE AND ALLEGEDLY TIPPED OVER ON TOP OF THE PATIENT. THE FATHER OF THE PATIENT STATED THAT A POSITIONAL BELT WAS IN USE AT THE TIME AND THAT THE PATIENT REMAINED IN THE WHEELCHAIR THROUGHOUT THE EVENT. THE PATIENT WAS REPORTED TO HAVE BROKEN BOTH ANKLES AND TAKEN TO THE HOSPITAL. IT WAS REPORTED THAT THE DOCTORS ADMINISTERED MEDICATION THAT CAUSED COMPLICATIONS TO THE PATIENT'S RESPIRATORY FUNCTION AND THE FOLLOWING DAY THE PATIENT PAST AWAY. BASED UPON THE INFORMATION COLLECTED IN THIS INVESTIGATION THE DOWNHILL SLOPE WAS AT THE MAX LIMITATION OF 10 DEGREES AND CONCRETE WAS WET. THE OWNER'S MANUAL WARNS USERS NOT TO DRIVE DOWN OR UP A HAZARDOUS INCLINE, SUCH AS A SURFACE COVERED WITH SNOW, ICE OR WET LEAVES OR A SURFACE THAT IS UNEVEN. IT ALSO STATES YOU SHOULD ALWAYS DRIVE DOWNHILL AT LOW SPEED AND WITH GREAT CAUTION AND TO AVOID BRAKING AND SUDDEN EVASIVE MANEUVERS AS ONE COULD LOSE CONTROL AND BE AT RISK OF INJURY. DURING INSPECTION, THE POSITIONAL BELT WAS FOUND BUCKLED UNDERNEATH THE SEATING SYSTEM AS IF NOT IN USE. THE WHEELCHAIR WAS EVALUATED AND THERE WAS NO EVIDENCE OF THE WHEELCHAIR SUSTAINING DAMAGES OR SCRATCHES AS WE WOULD EXPECT TO SEE FROM TIPPING OVER AND LANDING ON THE CONCRETE. FURTHERMORE, THE WHEELCHAIR WAS TESTED AND OPERATED ACCORDING TO FACTORY SPECIFICATION. DUE TO THE LACK OF SUPPORTING EVIDENCE WE ARE UNABLE TO CONFIRM THIS COMPLAINT. THERE WILL BE NO LONG-TERM CORRECTIVE ACTIONS TAKEN. THE DHR FOR THIS DEVICE HAS BEEN REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTS ARE THAT THE PATIENT DROVE HIS WHEELCHAIR IN A DOWNHILL HALL IN A PARKING GARAGE WHERE THE CONCRETE WAS WET DUE TO RAIN. UPON APPLYING THE BRAKE, THE WHEELCHAIR TIPPED FORWARD AND PATIENT FELL OUT OF THE DEVICE AND INJURED HIS FEET. PATIENT WAS TAKEN TO THE HOSPITAL FROM WHICH THE PATIENT DIED A DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874938 PERMOBIL C400 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death