BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTIVE EQUIPMENT SYSTEMS

    MDR report key: 1713579 · Received June 7, 2010

    Report

    Report Number
    2937137-2010-00008
    Event Type
    Death
    Date Received
    June 7, 2010
    Date of Event
    July 28, 2007
    Report Date
    May 10, 2010
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/10/2010, MFR RECEIVED PHOTOGRAPHS OF THE PRODUCT IN ITS CURRENT CONDITION LOCATED AT THE ATTORNEY'S OFFICE MORE THAN 2 YEARS AFTER THIS EVENT OCCURRED. IN VIEWING PHOTOS AT THIS TIME, NO PRODUCT FAILURE IS APPARENT, HOWEVER, THE BOTTOM BRACKET ON THE RIGHT SIDE OF THE BACKREST DOES NOT APPEAR TO BE LATCHED PROPERLY IN PLACE. THIS COULD BE DUE TO REMOVING AND REPLACING BACKREST, BUT UNABLE TO STATE IF IT WAS PRIOR TO THE STATED EVENT OR SOMETIME FOLLOWING THE EVENT. THE MFR WAS NOTIFIED OF THIS EVENT MORE THAN 2 YEARS AFTER IT HAD OCCURRED. UNABLE TO FIND ANY COMPLAINTS RECEIVED PRIOR TO THIS EVENT FOR THIS SPECIFIC PRODUCT OR ANY SIMILAR COMPLAINTS RELATED TO LIKE PRODUCT. MANUFACTURER HAS NOT RECEIVED ENOUGH INFORMATION TO MAKE ANY CONCLUSIONS AT THIS TIME AS TO WHAT CAUSED THE STATED EVENT. PRODUCT HAS NOT BEEN RETURNED OR IS EXPECTED TO BE RETURNED TO MANUFACTURER FOR EVALUATION. PRODUCT (BACK REST WITH CUSHION AND BRACKET HARDWARE) WAS ORDERED AS PARTS TO BE INSTALLED ON ANOTHER MANUFACTURER'S WHEELCHAIR. THE MANUFACTURER WILL CONTINUE TO REQUEST ADDITIONAL INFORMATION RELATED TO THIS EVENT AND SUBMIT UP REPORTS AS INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REPORTER STATED THAT ON (B) (6) 2007, THE PLAINTIFF WAS TRANSPORTING THE DECEASED IN HER VEHICLE. WHILE TRAVELING THE BACK/BACKREST OF THE WHEELCHAIR CAME FREE CAUSING THE DECEDENT TO LURCH FORWARD AND SUSTAIN SERIOUS PERSONAL INJURIES. THE ACCIDENT WHICH CAUSED SERIOUS PERSONAL INJURIES TO THE DECEDENT ULTIMATELY RESULTED IN HIS DEATH ON (B) (6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTIVE EQUIPMENT SYSTEMS SUPPORT, HEAD AND TRUNK, WHEELCHAIR IOR SUNRISE MEDICAL, INC. SOLID BACK SBK10XX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death