MAUDE Adverse Event Report: UNKNOWN DRIVE; ASSIST RAIL

Model Number	RTL15063-ADJ
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	12/25/2016
Type of Reportable Event	Death
Event or Problem Description
On december 17, 2021, drive received a report that in (b)(6) 2016, an end-user of the subject bed handle died as a result of becoming entrapped between the handle and the mattress of his bed.Drive did not receive any further information in the report, and is currently investigating.The bed handle is the subject of a voluntary recall that was announced by the cpsc and health (b)(4) on (b)(6) 2021.The cpsc recall announcement is attached.Drive will update this report if and when further information becomes available.

• Brand Name: DRIVE
• Common Device Name: ASSIST RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13083065
• Report Number: 2438477-2021-00077
• Device Sequence Number: 5711280
• Product Code: IKX
• UDI-Device Identifier: 00822383246192
• UDI-Public: 822383246192
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/16/2021
• Report Date (Section F): 12/16/2021

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: Health Professional
• Device Model Number: RTL15063-ADJ
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2021
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2021
• 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 Age: 87 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/16/2021