MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. TRANSCEND W/POWERTRAXX

Model Number	0731403
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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported while transporting a patient on the chair, a screw allegedly fell out from the seat assembly area.The alleged issue did not affect the ability to complete the patient transport and there were no associated injuries.An authorized field technician was dispatched to the customer's location to conduct a visual and functional evaluation.The alleged issue was confirmed and new hardware was installed on the chair and the chair was returned to service.

• Brand Name: TRANSCEND W/POWERTRAXX
• Common Device Name: TRANSCEND W/POWERTRAXX
• 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: 24052442
• Report Number: 1523574-2026-00003
• Device Sequence Number: 9348773
• Product Code: FPO
• UDI-Device Identifier: 00190790004064
• UDI-Public: (01)00190790004064(11)240402
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: 0731403
• Device Catalogue Number: 0731403
• Device Lot Number: M840120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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
• Patient Sex: Unknown