BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 7599356 · Received June 13, 2018

    Report

    Report Number
    2937137-2018-00007
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    August 1, 2016
    Report Date
    September 5, 2018
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR FILING IS TO CORRECT THE WHEELCHAIR SERIAL NUMBER FROM (B)(4) TO (B)(4). SERIAL NUMBER (B)(4) IS A REPLACEMENT WHEELCHAIR FOR THE END USER. THE ADVERSE EVENT OCCURRED WHILE THE END USER WAS USING WHEELCHAIR (B)(4). A SECOND CORRECTION IS BEING MADE TO THE 510(K) NUMBER LISTED. THE CORRECT 510(K) NUMBER FOR THIS DEVICE IS K973673. THANK YOU.

    Description of Event or Problem · 0

    THIS MDR FILING IS TO CORRECT THE WHEELCHAIR SERIAL NUMBER ONLY. THE WRONG SERIAL NUMBER WAS ENTERED IN THE ORIGINAL MDR. SEE ORIGINAL MDR FOR MORE INFORMATION ON THE INCIDENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT WHEELCHAIR HAS BEEN CONFIRMED BY SUNRISE MEDICAL (US) LLC TO HAVE BEEN AFFECTED BY THE VOLUNTARY RECALL INITIATED ON 7/5/2016 BY SUNRISE MEDICAL FOR THE QUICKIE Q7 BACKREST BRACKETS. THIS ISSUE IS ADDRESSED IN CAPA (B)(4). IN RESEARCHING THE HISTORY OF THIS WHEELCHAIR, SUNRISE MEDICAL RECEIVED NOTICE ON 1/25/2017 BY WAY OF AN ACKNOWLEDGEMENT AND RESPONSE FORM VIA EMAIL FROM (B)(4) STATING THAT THE BACKREST BRACKETS WERE REPLACED WITH THE UPGRADED BRACKETS AND REPAIRS WERE COMPLETED BY (B)(4). ON 1/11/2017. AT THE TIME OF RECEIVING THIS INFORMATION OR ANY TIME PRIOR TO (B)(4) REPAIR NOTICE, SUNRISE MEDICAL WAS NOT MADE AWARE OF AN ADVERSE EVENT INVOLVING A SERIOUS INJURY OR MALFUNCTION OF THE PRODUCT. THE LEGAL COMPLAINT RECEIVED ON MAY 15, 2018 IS THE FIRST SUNRISE MEDICAL WAS MADE AWARE OF AN ADVERSE EVENT INVOLVING THE SUBJECT WHEELCHAIR. SUNRISE MEDICAL'S LEGAL DEPARTMENT IS CURRENTLY ADDRESSING THIS COMPLAINT.

    Description of Event or Problem · 1

    A LEGAL COMPLAINT NOTICE WAS RECEIVED BY SUNRISE MEDICAL (US) LLC ON MAY 15, 2018 FROM THE COURT OF COMMON PLEAS OF (B)(6) STATING THE FOLLOWING ALLEGATION: IN OR ABOUT (B)(6) 2016, PLAINTIFF WAS GETTING THE MAIL AT HIS HOME. WHEN PLAINTIFF WAS REACHING FOR HIS MAIL, THE BACKREST BRACKET OF HIS QUICKIE Q7 WHEELCHAIR SUDDENLY AND WITHOUT NOTICE BROKE. THIS FAILURE OF THE BACKREST BRACKET CAUSED PLAINTIFF'S BODY TO INVOLUNTARILY FALL BACKWARD IN THE CHAIR, CHANGING THE CENTER OF BALANCE. THIS IMMEDIATELY MADE PLAINTIFF'S WHEELCHAIR UNSTABLE AND CAUSED IT TO TIP OVER BACKWARD, EJECTING PLAINTIFF FROM THE CHAIR. IN THE COURSE OF BEING THROWN FROM THE CHAIR, PLAINTIFF STRUCK HIS HEAD AND UPPER SPINE ON A CONCRETE FLOOR, KNOCKING HIM UNCONSCIOUS. AS A RESULT OF THE FALL, PLAINTIFF WAS RUSHED TO (B)(6) MEDICAL CENTER BY AN EMERGENCY SQUAD. AMONG PLAINTIFF'S NUMEROUS PHYSICAL INJURIES ARE AN ACUTE BRAIN INJURY, SPINAL CORD INJURY, WEAKNESS AND LOSS OF FUNCTION IN HIS UPPER EXTREMITIES, SUSTAINED AND UNCONTROLLABLE MUSCLE SPASMS, AND EXTREME/UNREMITTING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441493 QUICKIE Q7 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization