MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE; BARIATRIC BED

Model Number	PLTCAB
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	04/27/2026
Type of Reportable Event	Death
Event or Problem Description
Drive medical was notified of an incident involving an assist rail by a provider, who reported that a resident's neck was wedged between the assist rail and the mattress and that the resident passed away.The bed and the assist rail involved are drive medical products.The mattress involved is a competitor's product, not a drive medical product.As part of its complaint review and evaluation process, drive medical will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BARIATRIC BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen; fujian, 36102 2; CH 361022
• MDR Report Key: 25300553
• Report Number: 2438477-2026-00028
• Device Sequence Number: 18520912
• Product Code: OSI
• UDI-Device Identifier: 00822383979526
• UDI-Public: (01)00822383979526
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2026
• Report Date (Section F): 05/27/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PLTCAB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2026
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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
• Patient Weight: 57 KG
• Date Report Sent to FDA: 05/27/2026