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	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported the stretcher allegedly is intermittently lowering abruptly when depressing the button.It was stated this issue has occurred during patient transport; however, there were no further details provided and there was no allegation of injury or harm resulting from the alleged issue.An authorized field technician was dispatched to the customer's location to conduct a visual and functional evaluation.It was determined the actuator was the contributing factor to the abrupt movement of the stretcher.The actuator was removed and replaced, proper movement of the stretcher was confirmed and it 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: 23767608
• Report Number: 1523574-2025-00111
• Device Sequence Number: 13402480
• Product Code: FPO
• UDI-Device Identifier: 00190790002183
• UDI-Public: (01)00190790002183(11)200703
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/10/2025

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: 0015807
• Device Catalogue Number: 0015807
• Device Lot Number: M735960
• 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: 11/11/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2020
• 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