BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE LXI

    MDR report key: 12229945 · Received July 27, 2021

    Report

    Report Number
    9616084-2021-00017
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    May 18, 2018
    Report Date
    May 18, 2018
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND INFORMATION: IT IS UNKNOWN THE CONDITION OF THE WHEELCHAIR AT THE TIME OF THE INCIDENT. IN THE LX/LXI OWNER'S MANUAL, PART NUMBER MK-100066 REV. B, IT IS OUTLINED ON PAGE 14, SECTION D. SAFETY CHECKLIST: RECOMMENDED SAFETY AND FUNCTION CHECKS FOR THE FRAME, CAMBER TUBES AND CROSSBRACE TO BE PERFORMED EVERY 6 MONTHS. IT ALSO STATES THAT THE USER OR CAREGIVER SHOULD PERFORM THESE WEEKLY AND MONTHLY CHECKS TO MAINTAIN THE SAFETY OF THEIR CHAIR. IF AN ITEM IS NOT WORKING PROPERLY, PLEASE CONTACT YOUR AUTHORIZED DEALER. DISCUSSION: CROSS-FRAME BREAKAGE DURING TRANSFER HAS THE POTENTIAL TO LEAD TO A FALL WHICH IS CLASSIFIED AS A POTENTIAL FOR SERIOUS INJURY OR DEATH. THEREFORE, THIS IS A REPORTABLE EVENT. CONCLUSION: ALTHOUGH THE END USER DID NOT SUSTAIN INJURIES THAT WERE LIFE THREATENING OR REQUIRED MEDICAL INTERVENTION, THERE IS POTENTIAL FOR SERIOUS INJURY WERE THIS INCIDENT TO RECUR. THEREFORE, OUT OF AN ABUNDANCE OF CAUTION, SUNRISE MEDICAL HAS DECIDED TO FILE AN MDR TO REPORT THIS INCIDENT. ADDITIONAL INFORMATION: THIS COMPLAINT HAS BEEN RE-REVIEWED AS A PART OF A FOUR-YEAR RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES. A LEGAL CONSULTING FIRM WAS CONSULTED FOR THE RETROSPECTIVE REVIEW. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    PER DEALER KEN, X-TUBE BROKE AT THE WELD ON THE LEFT SIDE UNDER THE SEAT. THE USER FELL WHILE TRYING TO TRANSFER FROM A CHAIR TO HIS WHEELCHAIR. THE END USER SUFFERED MINOR CUTS TO HIS LEFT LEG WITH SOME MINOR BLEEDING. THERE WAS SOME BRUISING AND PAIN TO HIS BUTTOCKS AT THE TIME OF THE FALL. HE DID NOT GO TO THE HOSPITAL TO SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126134 QUICKIE LXI MANUAL WHEELCHAIR IOR SUNRISE MEDICAL PRIVADA MISIONES EILXI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other