BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE DEVILBISS TRANSPORT/WHEELCHAIR

    MDR report key: 23507918 · Received November 10, 2025

    Report

    Report Number
    3007309323-2025-00054
    Event Type
    Death
    Date Received
    November 10, 2025
    Date of Event
    April 16, 2023
    Report Date
    October 15, 2025
    Manufacturer
    ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD
    Product Code
    IOR
    UDI-DI
    00612479223363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE WHEELCHAIR INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD. AND DISTRIBUTED BY DRIVE DEVILBISS HEALTHCARE. HOWEVER, ACCORDING TO THE INFORMATION PROVIDED BY THE ATTORNEY, THE LAP BELT WAS NOT SUPPLIED OR MANUFACTURED BY ZHENJIANG ASSURE, BUT BY ANOTHER COMPANY (BELT INC.). THEREFORE, THE PRODUCT INVOLVED ON OUR SIDE IS LIMITED TO THE WHEELCHAIR ONLY, AND THE SAFETY BELT IN QUESTION DOES NOT BELONG TO OUR SUPPLY SCOPE. WE WILL FULLY COOPERATE WITH DRIVE AND RELEVANT AUTHORITIES SHOULD ANY FURTHER INVESTIGATION OR CLARIFICATION BE REQUIRED.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A DRIVE WHEELCHAIR AND UNIDENTIFIED LAP BELT BY A LETTER FROM AN ATTORNEY ALLEGING THE END USER PASSED AWAY AFTER SLIDING DOWN IN THE WHEELCHAIR TO THE FLOOR, CAUSING THE LAP BELT TO BECOME TIGHT AROUND HER NECK LEADING TO ASPHYXIATION. INFORMATION PROVIDED BY THE ATTORNEY INDICATES THE LAP BELT WAS MANUFACTURED BY BELT INC AND NOT DISTRIBUTED BY DRIVE DERVILBISS HEALTHCARE. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861538 DRIVE DEVILBISS TRANSPORT/WHEELCHAIR WHEELCHAIR, MECHANICAL, PRODUCT CODE: IOR IOR ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD 146-SSP18RBDDA 00612479223363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death