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

Model Number	0015816
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported the hardware attaching the fastening post to the stretcher was found to be loose and required tightening.No incidents were associated with the stretcher as a result of the loose hardware.An investigation has been initiated.
Additional Manufacturer Narrative
An authorized field technician was dispatched to the customer location to conduct a visual and functional evaluation.The reported issue was confirmed and the stretcher was repaired according to the field correction instructions and the stretcher was returned to service.
Event or Problem Description
An end user reported the hardware attaching the fastening post to the stretcher was found to be loose and required tightening.No incidents were associated with the stretcher as a result of the loose hardware.An investigation has been initiated.

• 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: 23015531
• Report Number: 1523574-2025-00096
• Device Sequence Number: 10038750
• Product Code: FPO
• UDI-Device Identifier: 00190790003210
• UDI-Public: (01)00190790003210(11)250410
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0015816
• Device Catalogue Number: 0015816
• Device Lot Number: M066800
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0133-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown