BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKE PULSE

    MDR report key: 3405732 · Received September 4, 2013

    Report

    Report Number
    2937137-2013-00045
    Event Type
    Death
    Date Received
    September 4, 2013
    Date of Event
    December 19, 2011
    Report Date
    September 6, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    PMA / PMN Number
    K062701
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFORMATION CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AN ADVERSE EVENT WAS REPORTED TO SUNSIRE MEDICAL ON (B)(6) 2013. SUNRISE MEDICAL WAS INFORMED OF A DEATH INVOLVING AN END USER AND HER QUICKIE PULSE POWER CHAIR BY NOTICE OF SERVICE OF PROCESS. IT WAS REPORTED TO SUNRISE MEDICAL THAT THE END USER WAS BEING TRANSPORTED BY VAN WHILE SITTING IN HER POWER CHAIR. THE END USER'S VAN WAS STRUCK BY ANOTHER VEHICLE CAUSING THE POWER CHAIR TO FALL OVER. THE END USER SUFFERED MULTIPLE FATAL INJURIES WHICH ATTRIBUTED TO HER DEATH. ADDITIONAL INFORMATION ON THIS INCIDENT CAN'T BE OBTAINED AT THIS TIME DUE TO LEGAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438034 QUICKE PULSE WHEELCHAIR, POWER ITI SUNRISE MEDICAL (US) LLC. EIPW21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death