MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD Drive Prime Care Bed Model 903; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P903
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	05/31/2026
Type of Reportable Event	Death
Event or Problem Description
Drive medical was notified by a long-term care facility of an event involving a bed headboard, mattress, and rail.The facility reported that the resident's head became entrapped between the headboard and side rail, and the resident subsequently passed away.At the time of reporting, no information was available indicating whether a malfunction of the bed, side rail, or mattress occurred.The cause of death and circumstances surrounding the entrapment remain under investigation.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.Additional information will be submitted if it becomes available.

• Brand Name: Drive Prime Care Bed Model 903
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen; fujian, 36102 2; CH 361022
• MDR Report Key: 50840559
• Report Number: 2438477-2026-00064
• Device Sequence Number: 21398121
• Product Code: FNL
• UDI-Device Identifier: 00822383787350
• UDI-Public: (01)00822383787350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026
• Report Date (Section F): 09/21/2026

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: Health Professional
• Device Model Number: P903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2026
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• 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: Unknown
• Date Report Sent to FDA: 09/21/2026