BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q2H

    MDR report key: 6963334 · Received October 19, 2017

    Report

    Report Number
    9616084-2017-00010
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 21, 2017
    Report Date
    November 9, 2017
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL RESEARCHED THIS ISSUE AND FOUND THAT THE END USER CALLED THE DEALER, (B)(6), AGAIN ON (B)(6) 2017 TO REQUEST ADDITIONAL PARTS ADDED TO HIS PARTS ORDER. HE IS HAVING THEM SHIPPED TO HIM DIRECTLY SO HE CAN REPAIR HIS CHAIR. HE STATED THAT THE BACK BOLTS CAME LOOSE CAUSING THE BACK UPHOLSTERY TO RIP. HE STATED THE UPHOLSTERY WAS RIPPED IN THE PROCESS OF HIM TUMBLING OUT OF THE CHAIR. SUNRISE MEDICAL IS UNABLE TO DETERMINE IF A MALFUNCTION OCCURRED OR IF THE PRODUCT IS DEFECTIVE. SINCE THE END USER IS NOT AN AUTHORIZED DEALER OR A QUALIFIED SERVICE TECHNICIAN, IT IS UNKNOWN IF THE BOLTS WERE MOUNTED INCORRECTLY. (B)(6) BELIEVES THE END USER THREW THE UPHOLSTERY AWAY. THE REMAINING PARTS ARE DUE TO COME BACK TO SUNRISE MEDICAL FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL QUALITY INSPECTOR EVALUATED THE RETURNED PARTS ON (B)(6) 2017 AND DETERMINED THE FAILURE WAS NOT ABLE TO DUPLICATE. THERE WERE NO SIGNS OF MISUSE. IT IS POSSIBLE THAT SINCE THE END USER WAS THE ONE REPAIRING HIS OWN CHAIR AND IS NOT AN AUTHORIZED REPAIR TECHNICIAN FOR SUNRISE MEDICAL OR THE DEALER FROM WHERE HE PURCHASED THE CHAIR, THE PARTS WERE NOT INSTALLED CORRECTLY CAUSING THE FAILURE. THIS IS AN ISOLATED INCIDENT AND SUNRISE MEDICAL CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 1

    PER DEALER (B)(6) ON (B)(6) 2017, CLIENT STATES HE WAS JUST SITTING THERE AND WENT TUMBLING BACKWARDS. THERE WERE NO INJURIES. (B)(6) STATED AFTER SPEAKING WITH HER TECH (B)(6), WHO WORKED ON THE CHAIR, HE STATED THE WHOLE BACK NEEDS TO BE REPLACED. PER (B)(6), THE FAILURE HAPPENED ON LEFT SIDE. HE STATED THE SCREWS WERE NOT HOLDING.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL MDR 9616084-2017-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742918 QUICKIE Q2H WHEELCHAIR, MANUAL IOR SUNRISE MEDICAL PRIVADA MISIONES EIQ2N

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR