BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE PULSE 6

    MDR report key: 3547167 · Received November 14, 2013

    Report

    Report Number
    2937137-2013-00062
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    September 10, 2013
    Report Date
    November 8, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    ITI
    PMA / PMN Number
    K062701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER REPORTED TO SUNRISE MEDICAL THAT AFTER THE CASTER FELL OFF IT WAS MISPLACED IN BETWEEN THE TIME THE INCIDENT OCCURRED AND WHEN THE CHAIR WAS REPAIRED. DUE TO THIS, SUNRISE MEDICAL WILL NOT BE ABLE TO PERFORM AN INVESTIGATION FOR THIS PARTICULAR INCIDENT. NO FOLLOW UP REPORT WILL BE FILED. 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 INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A QUICKIE PULSE 6 WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013. THE DEALER REPORTED THAT THE FRONT LEFT CASTER HAD FALLEN OFF THE CHAIR. THERE WERE NO REPORTS OF ANY INJURY DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591411 QUICKIE PULSE 6 WHEELCHAIR, POWERED ITI SUNRISE MEDICAL (US) LLC. EIPW22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK