MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER X2

Model Number	0015816
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported while unloading the stretcher from the ambulance to conduct a patient transport, the stretcher hesitated when lowering the legs and then when they attempted to raise the legs to load the patient into the ambulance, the stretcher displayed an error code.The medic crew made the decision to pull the stretcher from service and call for a backup stretcher to continue the patient transport.It was reported the incident resulted in a 30 min delay to the transport; however, there were no allegations of the delay adversely affecting the patient.It was not reported if the medic crew attempted to use the manual mode feature to overcome the error code and complete the transport.
Event or Problem Description
An end user reported while unloading the stretcher from the ambulance to conduct a patient transport, the stretcher hesitated when lowering the legs and then when they attempted to raise the legs to load the patient into the ambulance, the stretcher displayed an error code.The medic crew made the decision to pull the stretcher from service and call for a backup stretcher to continue the patient transport.It was reported the incident resulted in a 30 min delay to the transport; however, there were no allegations of the delay adversely affecting the patient.It was not reported if the medic crew attempted to use the manual mode feature to overcome the error code and complete the transport.
Additional Manufacturer Narrative
The stretcher was returned to manufacturer for a visual and functional evaluation.The reported issue was confirmed and it was concluded the contributing factor was a malfunctioning pcb board.The board was replaced and the stretcher begain working as intended and the stretcher was returned to the customer.

• Brand Name: POWER X2
• Common Device Name: POWER X2
• 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: 23522672
• Report Number: 1523574-2025-00106
• Device Sequence Number: 9667080
• Product Code: FPO
• UDI-Device Identifier: 00190790003210
• UDI-Public: (01)00190790003210(11)250826
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/31/2025

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: 0015816
• Device Catalogue Number: 0015816
• Device Lot Number: M156000
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: Unknown