BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M300

    MDR report key: 7355150 · Received March 20, 2018

    Report

    Report Number
    1221084-2018-00019
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    January 31, 2014
    Report Date
    March 20, 2018
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL WAS CONTACTED BY A LAW FIRM REPRESENTING THE END-USER'S ESTATE REQUESTING PERMOBIL PROVIDE AN M300 FOR EVALUATION TO USE IN AN ACTIVE LITIGATION CASE. IT WAS AT THAT POINT PERMOBIL WAS MADE AWARE OF AN INCIDENT HAVING OCCURRED, 4 YEARS PRIOR, WHERE IT WAS REPORTED THE END-USER HAD DIED DUE TO ALLEGEDLY BEING STRANGULATED AFTER BECOMING TRAPPED AGAINST A HANDRAIL AT THE APARTMENT COMPLEX WHICH THEY HAD RESIDED. CLAIMS BEING MADE ARE AS THE END-USER MANEUVERED THE DEVICE ON TO A PATIO AREA EQUIPPED WITH A RAILING, AT SOME POINT THE DEVICE STRUCK THE BOTTOM OF THE RAILING CAUSING IT TO BREAK AWAY. REPORTS CLAIM WITH THE RAILING HAVING BROKEN, ALLOWED THE DEVICE TO DRIVE OVER THE EDGE OF THE PATIO CAUSING THE WHEELS TO DROP OFF THE EDGE. REPORTS CLAIM THE END-USER BECAME TRAPPED WITH THE TOP OF THE HAND RAIL RESTING ACROSS THEIR NECK WHICH EVENTUALLY LED TO THEIR DEATH DUE TO ASPHYXIATION BY STRANGULATION. NO ALLEGATIONS WERE MADE THAT THE DEVICE HAD MALFUNCTIONED OR HAD ANY DEVIATIONS WHICH MAY HAVE ATTRIBUTED TO THIS REPORTED EVENT. IT IS UNCLEAR AS TO THE STATUS OF THE DEVICE AS ITS WHEREABOUTS ARE CURRENTLY UNKNOWN. REVIEW OF THE DHR SHOWN DEVICE TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT ALLEGING END-USER HAVING BECOME TRAPPED BETWEEN THE DEVICE'S SEATING AND A PATIO HANDRAIL WHICH HAD ALLEGEDLY BROKEN. REPORTS CLAIM THE END-USER DIED AS THE RESULT OF ASPHYXIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197758 PERMOBIL M300 POWERED WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death