MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYE'S, INC DBA SIZEWISE MANUFACTURING; BEDSIDE LIFT

Model Number	38060000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was using a bedside patient lift to transfer out of bed when the lift malfunctioned and/or broke causing the patient to fall to the floor and fracture his knee.The two lifts that were in use by the patient are (b)(6) (ren107506) with manufacture date of 01-feb-2021 and (b)(6) (ren119300) with manufacture date of 08-jul-2022.Both lifts were the same model and udi number.This event occurred on 16-sep-2023.The initial notification received on 20-may-2024 indicated that the patient experienced a fall and sustained a fractured knee which did not warrant an mdr at that time.A subsequent notification received on 05-march-2026 reported that the patient sustained serious injuries, therefore, mdr submission is now warranted.
Additional Manufacturer Narrative
Specific injury details have not been provided.Investigation is currently underway via agiliti complaint complaint-(b)(4).Product was recalled on 02-jan-2024 requesting that devices be destroyed.The patient was contacted three times via phone.The patient has declined pickup and has not provided confirmation of device destruction.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: BEDSIDE LIFT
• Manufacturer (Section D): AGILITI HEALTH - HAYS; 500 commerce pkwy; hays KS 67601
• Manufacturer (Section G): AGILITI HEALTH - HAYS; 500 commerce pkwy; hays KS 67601
• Manufacturer Contact: bethany schultz ; 500 commerce pkwy; hays, KS 67601
• MDR Report Key: 24783067
• Report Number: 1931307-2026-00001
• Device Sequence Number: 13243220
• Product Code: FNG
• UDI-Device Identifier: 00845699001033
• UDI-Public: 00845699001033
• 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: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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
• Device Model Number: 38060000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 191 KG