MAUDE Adverse Event Report: UNKNOWN DRIVE; BED RAIL

Model Number	15201ABV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	06/28/2020
Type of Reportable Event	Death
Event or Problem Description
(b)(4) is the initial importer of the device which is a bed rail.The incident was reported to (b)(6).We are filing this report prior to completion of our investigation.The report will be amended when additional information is acquired.The end-user was in hospice care.His equipment was changed within the last two (2) weeks of his life including his bed rail, low air loss mattress and hospital bed.The facility was independent living, advanced care home.He was placed on a two(2) hour watch since he had been trying to exit the bed to get a drink.A care worker found him trapped under the bed rail with his feet resting on the ground.He died of accidental, mechanical asphyxiation.The nurse on staff that evening is no longer an employee of the hospice and is therefore unavailable for comment.The hospital supervisor reported that the devices were returned to the service provider after the incident.She advised that there were no issues or concerns with the rails, mattresses, and hospital bed.There was no investigation of the products at the hospice level, drive has unable to independently verify the configuration of the products since they were disassembled and returned to the provider before drive was notified of the incident.The product has been unavailable for evaluation.Root cause has not been determined.

• Brand Name: DRIVE
• Common Device Name: BED RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11935305
• Report Number: 2438477-2021-00022
• Device Sequence Number: 19607587
• Product Code: IKX
• UDI-Device Identifier: 00822383143026
• UDI-Public: 822383143026
• 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: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2021
• Report Date (Section F): 06/02/2021

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: 15201ABV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/15/2021
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2021
• 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 Weight: 76
• Date Report Sent to FDA: 06/02/2021