MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE DEVILBISS TRANSPORT/WHEELCHAIR; WHEELCHAIR, MECHANICAL, PRODUCT CODE: IOR

Model Number	146-SSP18RBDDA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Strangulation (2084)
Date of Event	04/16/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: DRIVE DEVILBISS TRANSPORT/WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL, PRODUCT CODE: IOR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no 799 chuqiao road; zhenjiang, jiangsu 21200 9; CH 212009
• Manufacturer (Section G): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no 799 chuqiao road; zhenjiang, jiangsu 21200 9; CH 212009
• Manufacturer Contact: ying mei ; no 799 chuqiao road; zhenjiang, jiangsu 21200-9 ; CH 212009
• MDR Report Key: 23507918
• Report Number: 3007309323-2025-00054
• Device Sequence Number: 8911105
• Product Code: IOR
• UDI-Device Identifier: 00612479223363
• UDI-Public: (01)00612479223363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 146-SSP18RBDDA
• Device Catalogue Number: 146-SSP18RBDDA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female