BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN ASPIRE

    MDR report key: 2060804 · Received March 11, 2011

    Report

    Report Number
    2937137-2011-00004
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 25, 2011
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, SUNRISE MEDICAL (US) LLC RECEIVED A COPY OF THE INCIDENT REPORT FROM THE (B)(6) FIRE DEPARTMENT. THE REPORT READS AS FOLLOWS: QUINT 1 RESPONDED TO (B)(4) ON A REPORT OF A WHEELCHAIR FIRE. ON THE SCENE, (B)(4) HAD COMMAND. WE HAD WHEELCHAIR FULLY INVOLVED AND NO EXPOSURES. WE USED THE FRONT BUMPER TRASH LINE TO EXTINGUISH THE FIRE. OWNER OF THE WHEELCHAIR SAID THAT HE NOTICED THE CHAIR HAD STOPPED AND THAT THE LIGHTS ON THE CONTROL PANEL STARTED GOING ON AND OFF. THEN HE NOTICED A FIRE UNDER THE SEAT AREA. OWNER WAS ABLE TO GET OFF THE WHEELCHAIR AND ATTEMPTED TO EXTINGUISH THE FIRE, BUT WAS UNABLE TO. THE OWNER ADVISED THAT THERE HAD BEEN NO PROBLEM WITH THE UNIT. WE LOOKED AT THE UNIT, BUT WERE UNABLE TO DETERMINE WHAT CAUSED THE FIRE. THE WHEELCHAIR HAS NOT BEEN RETURNED TO THE MANUFACTURER BY THE END USER AND IT'S CURRENT LOCATION IS UNKNOWN. IT IS UNKNOWN IF OR WHEN THE MANUFACTURER MAY HAVE AN OPPORTUNITY TO EVALUATE THE DEVICE. MANUFACTURER DOES NOT HAVE ALL OF THE DETAILS OF THE REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION OR TO CONFIRM THE IDENTITY OF THE WHEELCHAIR.

    Description of Event or Problem · 1

    END USER'S WIFE CALLED IN COMPLAINT ON (B)(6) 2011. THE ALLEGED INCIDENT HAPPENED ON (B)(6) 2011 AT APPROXIMATELY 5 PM. THE END USER WAS WALKING HIS DOG AND TAKING HIS NEWSPAPER TO HIS NEIGHBOR. HE WENT DOWN HIS DRIVEWAY AND TO THE NEIGHBOR'S HOUSE ACROSS THE STREET TO GIVE HER HIS NEWSPAPER. HE GOT UP OUT OF THE CHAIR AND AS HE DID, HE COULD SMELL SOMETHING BURNING. HE LAID THE NEWSPAPER ON THE NEIGHBOR'S PORCH, AND IN THE TIME IT TOOK HIM TO TURN AROUND, THE CHAIR HAD CAUGHT FIRE AND WAS ENGULFED IN FLAMES. AT THAT POINT, THE END USER CALLED 911. THE FIRE DEPARTMENT ARRIVED IN APPROXIMATELY 5 MINUTES, BUT ALL THEY COULD DO WAS CONTAIN THE FIRE AND MAKE SURE IT DID NOT SPREAD TO THE NEIGHBOR'S BUSHES OR HOUSE. NO INJURIES SUSTAINED BY THE END USER AS HE WAS APPROXIMATELY 3 FEET AWAY FROM THE CHAIR. NO SERIAL NUMBER IS AVAILABLE; ACCORDING TO THE CALLER, IT WAS BURNED OFF IN THE FIRE. THE CHAIR INVOLVED IN THE ALLEGED INCIDENT DOES NOT HAVE ANY LEGIBLE IDENTIFICATION AS A RESULT OF THE FIRE. THE CALLER STATED IT WAS AN "ASPIRE" POWER WHEELCHAIR PURCHASED FROM A FRIEND IN (B)(6) 2011. THE FRIEND SAID SHE PURCHASED THE CHAIR "NEW" IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN ASPIRE WHEELCHAIR, POWERED/ITI ITI SUNRISE MEDICAL (US) LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening