BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE

    MDR report key: 20659506 · Received November 11, 2024

    Report

    Report Number
    3019677893-2024-00007
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    March 20, 2024
    Report Date
    November 8, 2024
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    PMA / PMN Number
    K142457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND QUICKIE Q300M MINI OWNER'S MANUAL, PAGE 15 STATES: BATTERY ACID CAN CAUSE BURNS TO THE SKIN AS WELL AS DAMAGE TO FLOORS, FURNITURE AND YOUR WHEELCHAIR. IF BATTERY ACID COMES INTO CONTACT WITH THE SKIN OR CLOTHING, WASH IMMEDIATELY WITH SOAP AND WATER. IF BATTERY ACID COMES INTO CONTACT WITH THE EYE, IMMEDIATELY FLOOD THE EYE WITH RUNNING COLD WATER FOR AT LEAST 10 MINUTES AND SEEK MEDICAL ATTENTION IMMEDIATELY. DISCUSSION: THE SUNRISE MEDICAL LEGAL DEPARTMENT RECEIVED A COMPLAINT IN A CIVIL ACTION THAT ALLEGED THE END USER EXPERIENCED SERIOUS INJURIES RESULTING FROM THE SECONDHAND BATTERIES INSTALLED ON HIS Q300M WHEELCHAIR. IN THE CIVIL COMPLAINT, THE END USER STATED DURAMED SOLD HIM THE WHEELCHAIR WHICH OPERATED USING TWO (2) BATTERIES WIRED TO THE WHEELCHAIR'S CONTROL SYSTEM. THE END USER STATED A DURAMED REPRESENTATIVE PERFORMED SERVICE, MAINTENANCE, AND REPAIRS ON HIS WHEELCHAIR. THE END USER STATED THE ORIGINAL BATTERIES INSTALLED ON THE WHEELCHAIR DIED SOON AFTER HE PURCHASED THE WHEELCHAIR. THE END USER STATED THE DURAMED REPRESENTATIVE PERFORMED MOST OF THE SERVICE CALLS AND AT ONE CALL, THE REPRESENTATIVE INSTALLED TWO (2), USED MK BATTERIES (MANUFACTURED BY EAST PENN MANUFACTURING CO.) ON THE WHEELCHAIR. THE END USER STATED HE BEGAN HAVING ISSUES WITH THE WHEELCHAIR'S SPEED, STOPPING, ETC. AFTER THE BATTERY INSTALLATION. THE END USER STATED HE ALSO EXPERIENCED COUGHING IN HIS HOME, HEADACHES, AND SKIN RASHES. THE END USER STATED, APPROXIMATELY ON (B)(6) 2024, HE NOTICED A FOUL SMELL AND HEARD A "BOILING" NOISE COMING FROM THE MK BATTERIES, SO HE UNPLUGGED THE WHEELCHAIR. THEREAFTER, HE NOTICED "WHITE DUST" ON THE WHEELCHAIR. THE END USER STATED ON (B)(6) 2024, DURAMED SENT A DIFFERENT, UNNAMED SERVICE TECHNICIAN TO EVALUATE THE REPORTED ISSUES. THE END USER STATED THAT HE REPORTED TO THE TECHNICIAN THAT HE BELIEVED THE MK BATTERIES WERE LEAKING ACID AND SHOWED HIM THE "WHITE DUST/POWDER" ON THE WHEELCHAIR. THE END USER STATED DURAMED SENT A TECHNICIAN TO REMOVE THE BATTERIES FROM THE END USER'S HOME. THE END USER STATED HE WARNED THE TECHNICIAN THE BATTERIES WERE LEAKING ACID, AND THE TECHNICIAN DENIED THIS CLAIM BUT AGREED TO REMOVE THE BATTERIES FROM THE HOME WHILE LEAVING THE WHEELCHAIR. THE END USER STATED HE DID NOT USE THE WHEELCHAIR ANYMORE BECAUSE IT DID NOT HAVE BATTERIES. AFTER SHOWING A DURAMED TECHNICIAN THE WHITE DUST ON THE WHEELCHAIR AGAIN, A TECHNICIAN REMOVED THE WHEELCHAIR FROM THE END USER'S HOUSE AROUND (B)(6) 2024. THIS DURAMED TECHNICIAN WAS NOT THE ORIGINAL TECHNICIAN WHO INSTALLED THE MK BATTERIES EITHER. THE END USER STATED THE ACID DUST (AFOREMENTIONED "WHITE DUST") "ATE" HIS FLESH TO THE BONE ON MULTIPLE AREAS OF HIS BODY, AND AS A RESULT, THE END USER UNDERWENT EXTENSIVE WOUND CARE, DEVELOPED INFECTIONS, AND OTHER UNNAMED COMPLICATIONS. THERE WAS NO FURTHER INFORMATION PROVIDED ON THE DEGREE OF THE WOUNDS OR WHAT TYPE OF TREATMENT WAS TAKEN. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED ON THE END USER'S CURRENT CONDITION. WHILE THE CIVIL ACTION CLAIMS DESIGN AND MANUFACTURING DEFECT OF THE QUICKIE WHEELCHAIR'S CONTROL SYSTEM AGAINST SUNRISE MEDICAL, THERE HAS BEEN NO EVIDENCE SUBMITTED TO SHOW THE CONTROL SYSTEM MALFUNCTIONED. THE Q300M WHEELCHAIR HAS NOT BEEN RETURNED TO SUNRISE MEDICAL FOR QUALITY EVALUATION. THE MK BATTERIES THAT EXPERIENCED THE "BOILING" AND LEAKAGE OF "WHITE DUST" WERE NOT MANUFACTURED OR PROVIDED BY SUNRISE MEDICAL. THE MK BATTERIES A DURAMED REPRESENTATIVE INSTALLED ON THE WHEELCHAIR WERE REPORTED TO HAVE BEEN PREVIOUSLY USED. THERE HAS BEEN NO INFORMATION PROVIDED ON THE MANNER THE BATTERIES WERE PREVIOUSLY USED OR THE CONDITION OF THE BATTERIES WHEN THEY WERE INSTALLED ON THE WHEELCHAIR. CONCLUSION: IN CONCLUSION, DUE TO THE ALLEGATION OF SERIOUS INJURIES THAT REQUIRED MEDICAL INTERVENTION (SEVERE WOUNDS LOCATED ON MULTIPLE AREAS OF THE BODY THAT REQUIRED EXTENSIVE WOUND CARE), THIS MDR IS BEING FILED. NOTE: THIS MDR WAS INITIALLY FILED ON NOVEMBER 8, 2024, ON TIME. A REVIEW OF THE 3RD ACKNOWLEDGEMENT SHOWS THAT THE REPORT FAILED. THE REPORT FAILURE DETAILS STATE THE WEIGHT VALUE IS REQUIRED WHEN PROVIDING A WEIGHT UNIT IN SECTION A4 OF THE MEDWATCH FORM. THERE WAS NO WEIGHT PROVIDED BY THE END USER SO THAT INFORMATION IS UNKNOWN. IT APPEARS THERE WAS A SYSTEM ERROR/GLITCH BECAUSE THERE WAS NO WEIGHT UNIT ENTERED INTO THE RESUBMITTED SOFTWARE. THE MEDWATCH FORM INCLUDED IN THE ZIP FILE PROVIDED TO WEBTRADER ALSO DID NOT HAVE ANY INFORMATION IN THE PATIENT WEIGHT FIELD. THIS MDR IS BEING RESUBMITTED.

    Description of Event or Problem · 0

    THE SUNRISE MEDICAL LEGAL DEPARTMENT RECEIVED A COMPLAINT IN A CIVIL ACTION THAT ALLEGED THE END USER EXPERIENCED SERIOUS INJURIES RESULTING FROM THE SECONDHAND BATTERIES INSTALLED ON HIS Q300M WHEELCHAIR. THE END USER STATED THE ORIGINAL BATTERIES INSTALLED ON THE WHEELCHAIR DIED NOT LONG AFTER HE PURCHASED THE WHEELCHAIR. THE END USER STATED THE DURAMED REPRESENTATIVE PERFORMED MOST OF THE SERVICE CALLS AND AT ONE CALL, THE REPRESENTATIVE INSTALLED TWO (2) USED MK BATTERIES (MANUFACTURED BY EAST PENN MANUFACTURING CO.) ON THE WHEELCHAIR. THE END USER STATED, APPROXIMATELY ON (B)(6) 2024, HE NOTICED A FOUL SMELL AND HEARD A "BOILING" NOISE COMING FROM THE MK BATTERIES. AS A RESULT, HE UNPLUGGED THE WHEELCHAIR AND THEREAFTER, NOTICED "WHITE DUST" ON THE WHEELCHAIR. HE LATER CLAIMED THIS "WHITE DUST" WAS BATTERY ACID DUST. THE END USER STATED THE ACID DUST "ATE" HIS FLESH TO THE BONE ON MULTIPLE AREAS OF HIS BODY, AND AS A RESULT, THE END USER UNDERWENT EXTENSIVE WOUND CARE, DEVELOPED INFECTIONS AND OTHER UNNAMED COMPLICATIONS. THE END USER STATED HE ALSO EXPERIENCED COUGHING IN HIS HOME, HEADACHES, AND SKIN RASHES. WHILE THE CIVIL ACTION CLAIMS DESIGN AND MANUFACTURING DEFECT OF THE QUICKIE WHEELCHAIR'S CONTROL SYSTEM AGAINST SUNRISE MEDICAL, THERE HAS BEEN NO EVIDENCE SUBMITTED TO SHOW THE CONTROL SYSTEM MALFUNCTIONED. THE Q300M WHEELCHAIR HAS NOT BEEN RETURNED TO SUNRISE MEDICAL FOR QUALITY EVALUATION. THE MK BATTERIES THAT EXPERIENCED THE "BOILING" AND LEAKAGE OF "WHITE DUST" WERE NOT MANUFACTURED BY SUNRISE MEDICAL. THE MK BATTERIES A DURAMED REPRESENTATIVE INSTALLED ON THE WHEELCHAIR WERE REPORTED TO HAVE BEEN PREVIOUSLY USED AND FROM THEIR WAREHOUSE. THERE HAS BEEN NO INFORMATION PROVIDED ON THE MANNER THE BATTERIES WERE PREVIOUSLY USED OR THE CONDITION OF THE BATTERIES WHEN THEY WERE INSTALLED ON THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058292 QUICKIE POWERED WHEELCHAIR ITI SUNRISE MEDICAL (US) LLC QUICKIE Q300M MINI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other