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	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/13/2025 agiliti received a call from the facility stating that the bed was dropping down to low position by itself.On 6/20/2025 agiliti received fda letter and medsun form 3500a (b)(4) that was submitted by (b)(6) hospital stating patient involvement and the following."the patient was utilizing a "loaner" bed with air mattress capabilities.This reporter lowered the bed after performing patient care and approximately 30 seconds after placing the bed in the lowest position available for safety, the bed dropped making a "boom" sound.The bed had dropped to the floor.".
Additional Manufacturer Narrative
Upon initial review of this report agiliti did not feel that an mdr was necessary.Evaluation was completed and the problem was unable to be confirmed as reported.After receiving updated information on 6/20/2025 the decision was made to submit an mdr out of abundance of caution due to an edge case where a patient could be sitting on the edge of the bed, if the bed suddenly dropped, the patient could fall from the bed which could cause fractures that would require surgical intervention.Note: (b)(6) hospital reported an immerse blower wcf1629 with serial numbers (b)(6) (b)(6) in their report, rather than the applicable evolution bedframe noted in this report.

• 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: 22312444
• Report Number: 1931307-2025-00017
• Device Sequence Number: 8830275
• Product Code: FNL
• UDI-Device Identifier: 00845699000562
• UDI-Public: 00845699000562
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: Health Professional
• Device Model Number: 33060400
• Was Device Available for Evaluation?: No
• 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: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2012
• 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