BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE QXI

    MDR report key: 6822202 · Received August 25, 2017

    Report

    Report Number
    9616084-2017-00006
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEALER TAB CALLED AND DISCUSSED WITH SUNRISE MEDICAL'S CUSTOMER SERVICE REPRESENTATIVE WHAT COULD HAVE POSSIBLY BEEN THE ISSUE WITH THE BOLT SHEARING OFF. AFTER DISCUSSION WITH CUSTOMER SERVICE, TAB DETERMINED IT COULD POSSIBLY BE THE WAY THE CLIENT IS TYING DOWN THE WHEELCHAIR TRANSIT WHICH COULD CAUSE STRESS ON THE CASTER HOUSING/BOLT. TAB STATED HE WOULD FOLLOW UP WITH CLIENT AND DISCUSS FURTHER. TAB STATED WHILE THEY HAVE MADE 5 OR 6 REPAIRS CLIENT HAS ONLY FALLEN OUT OF CHAIR A "COUPLE OF TIMES". HE ALSO STATED THEY HAVE NOT REPORTED ANY ISSUES AS THEY HAVE PREVIOUSLY REPAIRED WITH PARTS THEY HAVE IN STOCK. TAB STATED THE CLIENT USES THE CHAIR INDOORS AND WAS SITTING IN THE CHAIR WHEN THE BOLT SHEARED OFF CAUSING THE CASTER TO FALL OFF. TAB WAS ALSO GOING TO CHECK THE FRAME AS HE BELIEVES THE STRESS OF THE BOLT MIGHT BE CAUSING OTHER ISSUES. WHEN TAB CALLED BACK ON (B)(6) 2017 HE PLACED AN ORDER FOR THE CASTER PLATE BOLTS ONLY AS THERE WERE NO OTHER ISSUES FOUND WITH THE CHAIR. SUNRISE MEDICAL HAS REQUESTED FROM TAB TO ELABORATE ON THE OTHER "COUPLE OF TIMES" WHERE THE END USER HAS FALLEN OUT OF THE CHAIR AND TO DESCRIBE THE CIRCUMSTANCES IN WHICH THE FALLS OCCURRED. IT WAS ALSO NOT CLEAR IF THE END USER FELL DUE TO THIS SPECIFIC INCIDENT OR NOT. ON (B)(6) 2017 TAB CALLED IN TO REPORT THAT THE BOLT THAT WAS BEING USED ON THE CHAIR WAS AN AFTER-MARKET BOLT NOT PROVIDED BY SUNRISE MEDICAL. HE STATED THE BOLT WAS TOO LONG WHICH MAY HAVE COMPROMISED THE STRENGTH OF THE BOLT AS WELL. TAB ALSO STATED THE END USER ONLY FELL ONCE AND NOT A "COUPLE OF TIMES" AS PREVIOUSLY STATED. AGAIN, THERE WERE NO INJURIES. SUNRISE MEDICAL HAS DETERMINED THAT THERE WAS NO MALFUNCTION OR DEFECT THAT CAUSED THIS INCIDENT SINCE IT WAS STATED THAT AFTER-MARKET PARTS WERE USED. SUNRISE MEDICAL ALSO CONSIDERS THIS CASE CLOSED AND NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    PER DEALER TAB STATED THE LEFT BOLT ON THE CASTER PLATE HAS SHEARED OFF AND HAS MADE ITS WAY INTO THE FRAME. THERE WERE NO INJURIES. THE DEALER STATED THAT THE CHILD HAS FALLEN OUT OF THE CHAIR MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599984 QUICKIE QXI MANUAL WHEELCHAIR IOR SUNRISE MEDICAL PRIVADA MISIONES EIF6

    Patients

    Seq Age Sex Outcome Treatment
    1