BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE QRI

    MDR report key: 6918434 · Received October 5, 2017

    Report

    Report Number
    9616084-2017-00008
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 7, 2017
    Report Date
    October 24, 2017
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL RECEIVED PART ON (B)(6) 2017 AND AN EVALUATION WAS PERFORMED BY THE QUALITY ANALYST. AFTER INSPECTING THE PART IT WAS DETERMINED THAT SAID PART MEETS SPECIFICATION. THE CAMBER TUBE AS RECEIVED SHOWS NO SIGNS OF FAILURE. THE MOST LIKELY CAUSE OF THE INCIDENT WOULD BE ATTRIBUTED TO A LACK OF OR IMPROPER MAINTENANCE.

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL RESEARCHED THE HISTORY OF THIS CHAIR. THE ONLY REPAIR THAT WAS RECORDED DONE TO THIS CHAIR WAS THE REPLACEMENT OF A SPACER AND A SET SCREW TO THE QUICK RELEASE AXLE IN (B)(6) OF 2017 BECAUSE THOSE PARTS WERE MISSING. THIS INCIDENT REPORT WAS CONCLUDED WITH A PARTS ORDER FOR THE CAMBER KIT THAT RECEIVES THE QUICK RELEASE AXLE. THIS ITEM WAS SHIPPED TO THE DEALER ON 9/8/2017. SUNRISE MEDICAL HAS REQUESTED FROM THE DEALER THE RETURN OF THESE PARTS FOR AN EVALUATION. THE PARTS HAVE NOT YET BEEN RECEIVED. THERE IS NO INDICATION THAT A MALFUNCTION HAS OCCURRED OR IF THE PARTS ARE DEFECTIVE. IF AND WHEN THE ALLEGED FAILED PART IS RECEIVED AN EVALUATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE FILED WITH ANY RELEVANT FINDINGS.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL MDR 9616084-2017-00008.

    Description of Event or Problem · 1

    PER DEALER (B)(6), THE LEFT WHEEL FELL OFF THE CHAIR WHILE THE CLIENT WAS IN IT. THIS OCCURRED WHILE THE CLIENT WAS IN THE FRONT YARD. THE CLIENT FELL OUT OF THE CHAIR, HOWEVER, NO INJURIES OCCURRED. HE DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698642 QUICKIE QRI WHEELCHAIR, MANUAL IOR SUNRISE MEDICAL PRIVADA MISIONES EIR5

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR