MAUDE Adverse Event Report: UNKNOWN DRIVE; BED RAIL

Model Number 15201ABV

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 06/28/2020

Event Type  Death  

Event 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
• Type of Device: BED RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11935305
• MDR Text Key: 254217005
• Report Number: 2438477-2021-00022
• Device Sequence Number: 1
• Product Code: IKX
• UDI-Device Identifier: 00822383143026
• UDI-Public: 822383143026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2021,06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15201ABV
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Distributor Facility Aware Date: 06/15/2021
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 98 YR
• Patient Weight: 76