MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER X1

Model Number	0015807
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while transporting an obese patient on the stretcher, the patient leaned heavily to one side and the stretcher tipped over.There were no injuries reported as a result and the stretcher was able to be righted and the transport was completed.
Event or Problem Description
It was reported that while transporting an obese patient on the stretcher, the patient leaned heavily to one side and the stretcher tipped over.There were no injuries reported as a result and the stretcher was able to be righted and the transport was completed.
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation of the stretcher.There was observed damage as a result of the reported incident; however, the stretcher was operating as intended and there were no observations of anything that would have contributed to the alleged leaning and tipping of the stretcher.Unrelated preventive maintenance repairs were made and the stretcher was returned to service.

• Brand Name: POWER X1
• Common Device Name: POWER X1
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 wiel way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 wiel way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 21909819
• Report Number: 1523574-2025-00047
• Device Sequence Number: 11783305
• Product Code: FPO
• UDI-Device Identifier: 00190790002183
• UDI-Public: (01)00190790002183(11)211222
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 0015807
• Device Catalogue Number: 0015807
• Device Lot Number: M157560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown