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

Model Number	0015816
Medical Device Problem Codes	Loss of Power (1475); Mechanical Jam (2983); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Death
Event or Problem Description
The end user reported after arrival at the hospital with an active cardiac patient, while unloading the stretcher from the ambulance, the legs of the stretcher would not lower under power using the buttons on the stretcher.The manual release option was utilized to lower the legs and complete the transport into the hospital.The end user advised that an estimated two-minute delay was experienced during the unloading process.Patient details: male, approximately 220 lbs, patient was experiencing and being treated for cardiac arrest on scene and throughout transport.Cpr was being administered via lifeline arm.The patient was later pronounced deceased at the hospital.The end user advised that they evaluated the stretcher the next day and were unable to duplicate the reported issue and made the decision to keep the stretcher in service, in manual mode only, until evaluation.This continues to be an active investigation and additional information will be provided in a follow up report.
Event or Problem Description
The end user reported after arrival at the hospital with an active cardiac patient, while unloading the stretcher from the ambulance, the legs of the stretcher would not lower under power using the buttons on the stretcher.The manual release option was utilized to lower the legs and complete the transport into the hospital.The end user advised that an estimated two-minute delay was experienced during the unloading process.Patient details: maile, approximately 220 lbs, patient was experiencing and being treated for cariac arrest on scene and throughout transport.Cpr was being administered via lifeline arm.The patient was later pronounced deceased at the hospital.The end user advised that they evaluated the stretcher the next day and were unable to cuiplicate the reported issue and made the decision to keep the stertcher in service, in manual mode only, until evaluation.This continues to be an active investigation and additional information will be provided in a follow up report.
Additional Manufacturer Narrative
On april 7, 2026 and april 9, 2026, manufacturer's representative traveled to the end user's location to evaluate the subject power x2 stretcher and its interaction with the associated power f2 fastening system.Manual release mode was confirmed to be operating properly.The power x2 stretcher and power f2 fastening system were returned to service.

• 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; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; +1(937)283-2900
• MDR Report Key: 24689745
• Report Number: 1523574-2026-00028
• Device Sequence Number: 13188251
• Product Code: FPO
• UDI-Device Identifier: 00190790003210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

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: M260530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2026
• 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: Death
• Patient Sex: Male
• Patient Weight: 220 LB