BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 2

    MDR report key: 6901421 · Received September 28, 2017

    Report

    Report Number
    2937137-2017-00026
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL RECEIVED THE DAMAGED REAR FRAME AND WAS EVALUATED BY A QUALITY INSPECTOR ON (B)(6) 2015. THE FOLLOWING WAS FOUND: THE BACK FRAME BROKE ON THE UPRIGHT TUBE THROUGH THE TOP HOLE. THIS HOLE IS RESERVED FOR CHAIRS MANUFACTURED WITH THE ANGLE ADJUSTABLE BACKREST. I VERIFIED THIS CHAIR WAS NOT CONFIGURED WITH THIS OPTION. SOMEONE HAS MODIFIED THE CHAIR FROM ITS ORIGINAL CONFIGURATION, RESULTING IN THE FAILURE TO THE BACK FRAME. THE FRAME COMPONENTS WERE REPLACED UNDER WARRANTY AS AN ACCOMMODATION. BOTH THE RIGHT AND LEFT REAR SIDE FRAMES WERE ORDERED AND SHIPPED ON 8/24/2015. THIS ELECTRONIC MDR IS BEING SUBMITTED TO FDA FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY SUNRISE MEDICAL, INC. AS PART OF A CORRECTIVE AND PREVENTIVE ACTION DISCUSSED WITH FDA IN RESPONSE TO AN INSPECTIONAL OBSERVATION. THE REVIEW REQUIRED A DOCUMENTED REASSESSMENT OF EACH COMPLAINT FOR REPORTABILITY UNDER 21 CFR PART 803. AS A RESULT OF THE ASSESSMENT, THIS EVENT WAS IDENTIFIED AS MEETING THE REGULATORY REPORTING CRITERIA IN THE COMPANY'S CURRENT MDR PROCEDURE, AND IS BEING SUBMITTED TO FDA OUT OF AN ABUNDANCE OF CAUTION AND COMPLIANCE TO AID IN PROVIDING FDA WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 1

    PER DEALER, (B)(5), STATED THE END USER WAS DOING A PRESSURE RELIEF (REPOSITIONING ON CHAIR). THE CHAIR FELL OVER BACKWARDS AND THE PATIENT HIT HIS HEAD ON THE FLOOR. AN AMBULANCE CAME AND PUT HIM IN BED. THE DEALER ALSO STATED THE REAR SIDE FRAME IS BROKEN ON THE RIGHT SIDE, AT THE TOP WHERE THE BACK CANE GOES IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681560 QUICKIE 2 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC EIQ2N

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening