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

Model Number	0731401
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	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation at the customer's location.The reported issue was confirmed; however, cause could not be determined.New hardware was installed on the chair and the chair was returned to service.
Event or Problem Description
It was reported while transporting a patient on the chair, some of the bolts on the seat frame came out.The product issue did not adversely affect the transport and the medics were able to complete the transport manually.There were no injuries reported as a result.

• Brand Name: TRANSCEND
• Common Device Name: TRANSCEND
• 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: 22394312
• Report Number: 1523574-2025-00068
• Device Sequence Number: 21113869
• Product Code: FPP
• UDI-Device Identifier: 00190790004040
• UDI-Public: (01)00190790004040(11)240828
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/03/2025

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: 0731401
• Device Catalogue Number: 0731401
• Device Lot Number: M942530
• 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: 06/09/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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