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

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	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The end user contacted technical support to advise that the front transport caster had detached and they needed service.There was no report of patient involvement or injuries associated with the reported issue.Information for the non-warranty repair was provided to the customer.
Additional Manufacturer Narrative
To date, despite multiple attempts, the customer has not responded to confirm if the non-warranty repair of wheel on the chair has been completed.
Event or Problem Description
The end user contacted technical support to advise that the front transport caster had detached and they needed service.There was no report of patient involvement or injuries associated with the reported issue.Information for the non-warranty repair was provided to the customer.

• Brand Name: TRANSCEND W/PWRTRX
• Common Device Name: TRANSCEND W/PWRTRX
• 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: 22179871
• Report Number: 1523574-2025-00057
• Device Sequence Number: 9227594
• Product Code: FPO
• UDI-Device Identifier: 00190790004064
• UDI-Public: (01)00190790004064(11)220531
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/13/2025

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: 0731403
• Device Catalogue Number: 0731403
• Device Lot Number: M236790
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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