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

Model Number	0015816
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The end user's stretcher and fastening system were returned to the manufacturer for evaluation.Visual and functional testing was conducted.Manual operation of both the stretcher and fastening system was tested multiple times and operated as intended.The reported issue of the stretcher becoming stuck in the fastening system was able to be duplicated; however, the manual release operated as intended releasing the stretcher from its position.A replacement stretcher and fastening system were provided to the end user, who confirmed they were operating as intended.
Event or Problem Description
The end user reported that, upon arrival at the hospital with a critically ill, motor vehicle accident, patient, the stretcher became stuck in the fastening system (power f2 s/n (b)(6), and the power features were not operational.The crew attempted manual release but were unsuccessful, so a hospital bed was brought to the ambulance, and the patient was lifted from the stretcher and transferred into the hospital.The patient was reported to be experiencing a cardiac event.It was reported the following day that the patient passed away.The end user reported that the issue resulted in a delay of treatment and transport into the hospital facility.There have been no medical allegations that the delay contributed to the patient's outcome.

• 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: 25365775
• Report Number: 1523574-2026-00061
• Device Sequence Number: 10654639
• Product Code: FPO
• UDI-Device Identifier: 00190790003210
• UDI-Public: (01)00190790003210(11)250530
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 06/02/2026

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: M104050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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: Death
• Patient Sex: Male
• Patient Weight: 81 KG