MAUDE Adverse Event Report: AGILITI HEALTH - HAYS RAYE'S, INC DBA SIZEWISE MANUFACTURING; 120V LOW BED 39"

Model Number	33060200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint originally received 4/7/2025.Assessment of information provided resulted in decision not to submit mdr.Upon receipt of additional information on 5/28/2025, complaint was again assessed and mdr submission was deemed necessary.Device misuse: bedframe used in home (vs healthcare) setting.User sat at head end of bed while holding headboard and utilized the bed head-end raise function via hand controller to lift entire body weight to assist with standing.The improper weight distribution resulted in actuator and emc failures.
Event or Problem Description
Original submission on 4/7/2025 states bed's ecm is not working properly.Bed's up/down actuators and foot articulation actuators are not moving.Bed's head articulation has movement but is jerky.Bed's up/down actuators move if plugged into head articulation port.On 5/28/2025 learned of patient involvement without injury.

• Brand Name: RAYE'S, INC DBA SIZEWISE MANUFACTURING
• Common Device Name: 120V LOW BED 39"
• 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: 22137702
• Report Number: 1931307-2025-00013
• Device Sequence Number: 12799411
• Product Code: FNL
• UDI-Device Identifier: 00845699000012
• UDI-Public: 00845699000012
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: Lay User/Patient
• Device Model Number: 33060200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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: Male
• Patient Weight: 247 KG