MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWER F2; POWER F2, POWERED FASTENING SYSTEM

Model Number	0567093
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported the powered fastening system would not fully retract the carriage and stretcher when loading a patient into the ambulance.The medic crew transitioned into manual operation of the fastening system to complete the transfer to the hospital.Upon unloading at the hospital, the fastening system would then not release the stretcher from the fastener.The patient was lifted from the stretcher and onto a hospital stretcher that was brought out to the ambulance.There were no allegations of adverse health consequences to the patient as a result of the delay in loading and unloading.After the transport, the end user was able to release the stretcher from the fastener and repair the fastening system and stretcher.

• Brand Name: POWER F2
• Common Device Name: POWER F2, POWERED FASTENING SYSTEM
• 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: 25033071
• Report Number: 1523574-2026-00036
• Device Sequence Number: 10261312
• Product Code: FPO
• UDI-Device Identifier: 00190790006570
• UDI-Public: (01)00190790006570(11)251231
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 0567093
• Device Catalogue Number: 0567091
• Device Lot Number: M222530
• 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: 04/05/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2025
• 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