BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C300 PS JR

    MDR report key: 4925689 · Received July 20, 2015

    Report

    Report Number
    1221084-2015-00021
    Event Type
    Injury
    Date Received
    July 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THIS CHAIR WAS REVIEWED; THE DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. DUE TO THE LIMITED INFORMATION PROVIDED VIA MAIL, SEVERAL ATTEMPTS TO GAIN INFORMATION SURROUNDING THE ALLEGED COMPLAINT HAVE BEEN UNSUCCESSFUL. PERMOBIL HAS NOT BEEN ABLE TO CONFIRM IF THE DEVICE ITSELF CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED PERMOBIL WILL FILE A FOLLOW-UP REPORT. NOT AVAILABLE FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    ON JULY 24TH OF 2015, PERMOBIL RECEIVED THE FIRE INVESTIGATION REPORT FROM THE (B)(6) FIRE-RESCUE DEPARTMENT. THE REPORT NARRATIVE STATED THE ACCIDENTAL FIRE ORIGINATED IN, NEAR, OR AROUND THE ELECTRIC WHEELCHAIR IN THE LIVING ROOM ON THE WALL. THE REPORT ALSO STATED THAT THE PROBABLE CAUSE WAS AN UNSPECIFIED ELECTRICAL SHORT IN THE SUSPECT WHEELCHAIR. PERMOBIL HAS NOT BEEN UNABLE TO CONFIRM IF THE CHAIR MALFUNCTIONED OR IF IT WAS AN ELECTRICAL ISSUE WITH THE OUTLET IN THE HOME AS THE SUSPECT WHEELCHAIR HAS NOT BEEN MADE AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION RECEIVED IN THIS REPORT STATED THAT NO INJURIES WERE SUSTAINED DUE TO THIS EVENT. THIS INFORMATION RECEIVED WAS NOT AVAILABLE PRIOR TO THE INITIAL MDR REPORT SENT TO FDA ON 07/20/15.

    Description of Event or Problem · 1

    RECEIVED CORRESPONDENCE FROM A LAW OFFICE STATING THAT THE END USER REPORTED BODILY INJURY AND PROPERTY DAMAGE CAUSED BY A THERMAL INCIDENT IN WHICH A PERMOBIL WAS INVOLVED. REPEATED ATTEMPTS TO OBTAINED ADDITIONAL INFORMATION REGARDING EVENT HAVE NOT BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468375 PERMOBIL C300 PS JR POWERED WHEELCHAIR ITI PERMOBIL INC. C300

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening