MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER X2; POWER X2, POWERED AMBULANCE STRETCHER

Model Number	0015816
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported while attempting to load a pediatric patient who was in an isolette, the stretcher stopped responding to the powered input from the buttons after being engaged with the ambulance loading system.The medic team did not attempt manual operation and instead elected to call a backup ambulance to complete the transport which resulted in a delay.There were no allegations of adverse health consequences to the patient as a result of the delay in transport.After the patient was transferred to another stretcher, the end user advised they removed the battery and reinserted it which seemed to reset the stretcher and it began operating properly again.

• Brand Name: POWER X2
• Common Device Name: POWER X2, POWERED AMBULANCE STRETCHER
• 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: 25033015
• Report Number: 1523574-2026-00034
• Device Sequence Number: 10127157
• Product Code: FPO
• UDI-Device Identifier: 00190790003210
• UDI-Public: (01)00190790003210(11)250723
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/29/2026

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: 0015816
• Device Catalogue Number: 0015816
• Device Lot Number: M128830
• 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: 04/06/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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