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)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported upon arrival at a patient's home, the fastening system installed in the ambulance would not allow the stretcher to be unloaded from the ambulance.The end user confirmed the fastening system was operating properly prior to arrival on scene.The end user advised that the crew elected to not transition to manual operation of the system but rather they called for a backup ambulance to complete the patient transfer.This resulted in a reported 30 min delay.The patient's condition was reported as "having trouble breathing".There were no allegations that the delay resulted in an adverse health consequence for the patient.A follow up call to the end user was made and it was determined the fastening system had become unpaired with the stretcher which resulted in the disruption of the communication necessary for operation of the powered features.

• 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: 25033098
• Report Number: 1523574-2026-00032
• Device Sequence Number: 10097444
• Product Code: FPO
• UDI-Device Identifier: 00190790006570
• UDI-Public: (01)00190790006570(11)260130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• 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: M242370
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2026
• 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: Other
• Patient Sex: Female