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

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
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.
Additional Manufacturer Narrative
Drive devilbiss healthcare received the serial number and product number of the device.Sections d3, d4, d5, f13, and f14 were updated with this new information.

• Brand Name: DRIVE DEVILBISS TRANSPORT/WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; no.297/799, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 23304272
• Report Number: 2438477-2025-00054
• Device Sequence Number: 21327217
• Product Code: IOR
• UDI-Device Identifier: 00612479223363
• UDI-Public: (01)00612479223363
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025
• Report Date (Section F): 11/03/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/04/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Date Report Sent to FDA: 11/03/2025