MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYE'S, INC DBA SIZEWISE MANUFACTURING; 120V EVOLUTION BED W/SCALE 35"

Model Number	33060400
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection, black charring was identified on the underside of the head deck section and on the head end of the frame at the mounting point of the strain relief for the power cord.When inspecting the power cord, there was also an area that had char marks, showing bare metal wires exposed and the cord was compressed/pinched in that area.Findings indicate power cord was pinched between the head section and bedframe when head deck was lowered exposing bare wire.Contact between bare wire and metal bed frame and strain relief resulting in sparking.
Event or Problem Description
Customer reported power cord on bedframe was sparking while in patient use.No patient injuries were reported.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: 120V EVOLUTION BED W/SCALE 35"
• 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: kari brower ; 500 commerce pkwy; hays, KS 67601
• MDR Report Key: 22198068
• Report Number: 1931307-2025-00012
• Device Sequence Number: 21159904
• Product Code: FNL
• UDI-Device Identifier: 00845699000562
• UDI-Public: 00845699000562
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 33060400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2011
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown