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

Model Number	0731402
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	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported one of the front transport wheels on the chair became loose and detached from the frame during a patient transport.No injuries or adverse effects were reported as a result.The chair was evaluated by an authorized field technician and the issue was confirmed.It was noted the shank pin on the wheel was bent.The caster was replaced and the chair was returned to service.

• Brand Name: TRANSCEND W/TRX
• Common Device Name: TRANSCEND W/TRX
• 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: 21667701
• Report Number: 1523574-2025-00044
• Device Sequence Number: 12806815
• Product Code: FPP
• UDI-Device Identifier: 00190790004057
• UDI-Public: (01)00190790004057(11)230320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/21/2025

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: 0731402
• Device Catalogue Number: 0731402
• Device Lot Number: M511880
• 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: 02/21/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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