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	08/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance the drop frame of the stretcher allegedly disengaged and moved upward toward the backrest of the stretcher.The stretcher lowered abruptly about a foot from the ambulance and was caught by the medic.No injuries were reported as a result and the transport was able to be completed.An authorized field technician was dispatched to conduct a visual and functional evaluation of the stretcher.The drop frame was cycled through all positions and was found to be locking securely into each position and would not disengage with pressure applied.There was no damage to the locking teeth or notches observed either.The stretcher was loaded and unloaded from the ambulance and the incident could not be duplicated.Cause of the alleged malfunction could not be determined.

• 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: 23067176
• Report Number: 1523574-2025-00090
• Device Sequence Number: 21294564
• Product Code: FPO
• UDI-Device Identifier: 00190790002183
• UDI-Public: (01)00190790002183(11)250307
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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: M051650
• 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: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown