MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER F2

Model Number	0567093
Medical Device Problem Codes	Mechanical Problem (1384); 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 had to be manually lowered but then the carriage arms would not lower downward to release the stretcher from the loader.The crew was able to manually lower the carriage arms and complete the transport into the hospital.The end user advised 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 they were unable to duplicate the issue afer the incident and made the decision to keep the power f2 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 had to be manually lowered but then the carriage arms would not lower downward to release the stretcher from the loader.The crew was able to manually lower the carriage arms and complete the transport into the hospital.The end user advised 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 the transport.Cpr was being administered via lifeline arm.The patient was later pronounced deceased at the hospital.The end user advised they were unable to duplicate the issue after the incident and made the decision to keep the power f2 in service, in manual mode only, until the evaluation.This continues to be an active investigation and additional information will be provided in a follow up report.
Additional Manufacturer Narrative
On (b)(6) 2026 and (b)(6)2026, manufacturer's representative traveled to the end user's location to evaluate the subject power f2 fastening system and its interaction with the associated power x2 stretcher.The carriage arms were manipulated up and down and were confirmed to be operating properly.The power x2 stretcher and power f2 fastening system were returned to service.

• Brand Name: POWER F2
• Common Device Name: POWER F2
• 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: 24689746
• Report Number: 1523574-2026-00029
• Device Sequence Number: 9706105
• Product Code: FPO
• UDI-Device Identifier: 00190790006570
• 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): 07/22/2026

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: 0567093
• Device Catalogue Number: 0567091
• Device Lot Number: M255240
• 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: 02/19/2026
• 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