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

Model Number	0731405
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported missing hardware from the assembly connecting the seat frame to the mainframe of the chair.This observation was made during inspection and there was no adverse event or injury associated with the product issue.Replacement hardware was sent to the customer for installation.
Additional Manufacturer Narrative
The customer confirmed receipt of the repair parts and advised the chair was successfully repaired and returned to service.
Event or Problem Description
The end user reported missing hardware from the assembly connecting the seat frame to the mainframe of the chair.This obersvation was made during inspection and there was no adverse event or injury associated with the product issue.Replacement hardware was sent to the customer for installation.

• 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: 23888584
• Report Number: 1523574-2025-00115
• Device Sequence Number: 9622297
• Product Code: FPO
• UDI-Device Identifier: 00190790006334
• UDI-Public: (01)00190790006334(11)240415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 0731405
• Device Catalogue Number: 0731405
• Device Lot Number: M856330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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