BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZY EC2000

    MDR report key: 6902824 · Received September 28, 2017

    Report

    Report Number
    3006459587-2017-00007
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    October 29, 2015
    Report Date
    October 29, 2015
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE NATURE OF THE COMPLAINT, SUNRISE MEDICAL HAS FOUND THAT THERE IS NO EVIDENCE A MALFUNCTION OCCURRED. THE ROOT CAUSE OF THE ALLEGED ISSUE WAS UNABLE TO BE DETERMINED SINCE THE ITEM WAS NOT RETURNED FOR EVALUATION. IT IS POSSIBLE THE FALLS WERE DUE TO BALANCE ISSUES SINCE THE END USER'S LEG WAS BROKEN AND POSSIBLY LEANED FORWARD TOO FAR. THERE IS ALSO NO RECORD OF ANY REPLACEMENT PARTS REQUESTED FOR THIS CHAIR OR THIS CHAIR EVER BEING SERVICED BY A DEALER. 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 END USER, SAYS CHAIR TIPPED OVER FORWARD ON HER TWICE. THE FIRST TIME SHE WAS LEANING FORWARD TRYING TO PUT SOMETHING INTO A DRAWER. THE SECOND TIME IT HAPPENED TODAY AROUND 7:30A.M. SHE STATED SHE WAS PUTTING HER FOOT INTO HER BOOT (SHE'S IN WHEELCHAIR BECAUSE OF BROKEN LEG) AND IT TIPPED OVER ON HER FORWARD AND ENDED UP ON TOP OF HER. SHE HAD TO HAVE HER HUSBAND COME HOME FROM WORK AND GET THE CHAIR OFF HER BACK. SHE SAID IT INJURED HER BACK AND SHE'S GOING TO URGENT CARE. ALSO, SHE SAID THE CHAIR SCRATCHED HER ON HER LOWER LEFT BACK WHEN IT FELL, IT WASN'T A DEEP GASH BUT SHE WAS BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679519 BREEZY EC2000 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC 216RADPE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR