MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE MEDICAL 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	Strangulation (2084)
Date of Event	06/03/2026
Type of Reportable Event	Death
Event or Problem Description
Drive medical was notified of an incident involving a bed and assist rail.The reporting facility indicated that the end user attempted to exit the bed.During this attempt, the end user slipped and rotated toward the bed rail, resulting in positioning of her arm coming across her neck while contacting the rail and pillow.The end user subsequently passed away.The rails in use were identified as assist rails.It was reported that the bed involved in the incident was subsequently inspected by the ministry of health for canada and placed back into circulation the next day.The exact assist rails that were involved in the incident were unable to be located and had been moved to another bed.Exact patient age and weight cannot be obtained from the importer's mdr, hence the age and weight filled in this form are only estimated.
Additional Manufacturer Narrative
On june 13, 2026, an adverse event report concerning bed assist rails was provided by importer drive (mdr 2438477-2026-00034).As the manufacturer, we promptly launched an internal investigation.A spot check was performed by the quality department on bed-- sn: (b)(6), and the production batch records were verified to meet all requirements.Per the importer's report, drive medical had requested that the device involved in the incident returned for evaluation.It was reported that the bed involved in the incident was subsequently inspected by the ministry of health and placed back into circulation the next day.And the assist rails had already been disassembled and transferred to be used on another bed.As a result, the manufacturer is unable to identify the type of assist rails involved or confirm whether it was a product manufactured by us or not.Given the available information, it is not possible for us to conduct further analysis to determine the root cause, so there are no corrective actions for the time being.

• Brand Name: DRIVE MEDICAL PRIME CARE BED MODEL 903
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL,
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102 2; CH 361022
• Manufacturer (Section G): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102 2; CH 361022
• Manufacturer Contact: lisa huang ; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102-2 ; CH 361022
• MDR Report Key: 25632395
• Report Number: 3004168774-2026-00002
• Device Sequence Number: 9837242
• Product Code: FNL
• UDI-Device Identifier: 00822383787350
• UDI-Public: (01)00822383787350
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 06/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: P903
• Device Catalogue Number: P903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 57 KG