BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE MEDICAL

    MDR report key: 1695619 · Received May 21, 2010

    Report

    Report Number
    9616873-2010-00001
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    December 7, 2009
    Report Date
    April 21, 2010
    Manufacturer
    WU'S TECH CO., LTD.
    Product Code
    INI
    PMA / PMN Number
    K033032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED SCOOTER HAS NOT BEEN RETURNED TO WU'S TECH FOR EVAL. FOR INFO, POWER SCOOTERS MFG BY WU'S TECH ARE NOT EQUIPPED WITH A SEAT BELT. THE SEAT BELT ON THE ALLEGED SCOOTER MIGHT HAVE BEEN INSTALLED BY THE USER OR A THIRD PARTY. THE MANNER IN WHICH THE SEAT BELT WAS INSTALLED AND FUNCTIONALITY OF THE SEAT BELT IS UNK. IT WAS REPORTED THAT THE USER-INSTALLED SEAT BELT MIGHT HAVE CAUSED THE PT TO BE CONFINED ON THE SEAT AND THEREFORE, CONTRIBUTE TO THE INCIDENT. FOR FURTHER INFO, THE MAIN PURPOSE OF USING A POWER SCOOTER IS PROVIDING WALKING AID, NOT FOR GARBAGE DELIVERY. KEEPING LARGE OBJECTS IN BETWEEN DRIVER'S LEGS MAY IMPAIR DRIVER'S MANEUVERING CAPABILITY, IN ADDITION, TO THE DRIVER'S BODY WEIGHT AND PREEXISTING MEDICAL CONDITIONS. DAYTONA MODEL SCOOTERS WERE DESIGNED ACCORDING TO THE INDUSTRIAL STANDARD ISO (B) (4). SPECIFICALLY, THE BACKREST HAS PASSED ISO (B) (4), BACKREST: RESISTANCE TO IMPACT. OUR DEVICE HISTORY RECORD DEMONSTRATED THAT THE ALLEGED SCOOTER WITH (B) (4) INCLUDING THE SEAT/BACK ASSEMBLY HAS PASSED ALL QUALITY INSPECTIONS AS PER MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    ONE OF OUR DISTRIBUTORS IN THE UNITED STATES HAS RECEIVED AN ATTORNEY LETTER ALLEGING THE FOLLOWING INCIDENT: A PT DROVE A POWER SCOOTER FROM HER CONDOMINIUM TO DELIVER A BAG OF TRASH TO THE TRASH ROOM IN THE SAME BUILDING. IT WAS REPORTED THAT THE PT HAD A SEAT BELT ON AND WAS KEEPING THE TRASH BAG BETWEEN HER FEET ON THE SCOOTER. IT IS ALLEGED THAT WHILE IN THE TRASH ROOM THE SEAT BACK OF THE SCOOTER BROKE ALLEGEDLY CAUSING THE PT TO FALL BACKWARDS, STRIKING HER HEAD AND SUBSEQUENTLY DIED FROM ASPHYXIATION. THIS MDR REPORT IS BASED ON THE INFO PROVIDED BY (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL POWER SCOOTER INI WU'S TECH CO., LTD. DAYTONA GT 3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death