BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE QRI

    MDR report key: 3603448 · Received December 20, 2013

    Report

    Report Number
    9616084-2013-00010
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A MALFUNCTION INVOLVING A QUICKIE QRI WAS REPORTED TO SUNRISE MEDICAL ON (B)(6) 2013. THE DEALER IS ALLEGING THAT ONE OF THE REAR WHEELS HAD FALLEN OFF OF THE WHEELCHAIR WHILE THE OCCUPANT WAS IN MOTION. THE DEALER COULDN'T SPECIFY THE DATE OF THE ACTUAL INCIDENT. THERE WERE NO REPORTS OF ANY FALLS OR INJURY DUE TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668593 QUICKIE QRI WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL PRIVADA MISIONES EIR5

    Patients

    Seq Age Sex Outcome Treatment
    1