MAUDE Adverse Event Report: UNKNOWN DRIVE; ASSIST RAIL

Model Number	RTL15063-ADJ
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	10/05/2018
Type of Reportable Event	Death
Event or Problem Description
On january 3, 2022, (b)(6) healthcare was first notified of an entrapment incident that occurred in late (b)(6) or early (b)(6) 2018 involving the bed assist handle, which is subject to a voluntary recall in cooperation with the cpsc.The end user's daughter was notified of the recall in (b)(6) 2021, and contacted the company to report the 2018 incident.According to the report, the end user, who was a resident in hospice care, became entrapped and was bruised "all over on his arm and back." he was found by a nurse and transported to the hospital.It is unknown how long he was in the hospital, but it was reported that he died on (b)(6) 2018, which was 2 to 3 days after returning from the hospital.According to the report, he died due to "health complications" and/or "pneumonia." the reporter indicated that the bed assist handle at issue was discarded in 2018, so the company cannot inspect it.However, (b)(6) is currently investigating the incident and will file an update if and when additional information becomes available.(b)(6) encourages consumers who have the recalled bed handles to contact (b)(6) to participate in the voluntary recall and receive a refund.Please visit (b)(6), or call (b)(6) from 8:00 a.M.To 7:00 p.M.Et, monday through friday.

• Brand Name: DRIVE
• Common Device Name: ASSIST RAIL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 13240037
• Report Number: 2438477-2022-00001
• Device Sequence Number: 19954213
• Product Code: IKX
• UDI-Device Identifier: 00822383246192
• UDI-Public: 822383246192
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 01/07/2022
• Report Date (Section F): 01/08/2022

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: 01/07/2022
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2022
• 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; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 01/08/2022