MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX FOR INLINE

Model Number	0015811
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	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a transport wheel detached from the stretcher during a patient transport.The end user reported there were no injuries as a result of the reported issue; however, additional details of the incident were not provided.
Additional Manufacturer Narrative
The stretcher was returned to manufacturer and a visual and functional evaluation was conducted.The reported issue was confirmed.Visual observations included damaged and flattened threads on the subject wheel as well as a heavy amount of oil and debris in the threads.A new wheel assembly was installed and the stretcher was returned to the customer.
Event or Problem Description
It was reported a transport wheel detached from the stretcher during a patient transport.The end user reported there were no injuries as a result of the reported issue; however, additional details of the incident were not provided.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• 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: 21986055
• Report Number: 1523574-2025-00049
• Device Sequence Number: 18235066
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)210121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0015811
• Device Catalogue Number: 0015811
• Device Lot Number: M939890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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