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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while preparing to load the stretcher and patient into the ambulance, the stretcher tipped to the side.It was reported the patient was injured; however, details of the alleged injury and any needed medical intervention was not provided.Furthermore, no additional details were provided about the incident.The stretcher was removed from service pending evaluation.An authorized field technician was dispatched to conduct a visual and functional evaluation of the stretcher and there was no indication of equipment failure that would have caused the incident nor was there any evidence of equipment damage from the tip.This incident occurred in canada.

• 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: 22786277
• Report Number: 1523574-2025-00084
• Device Sequence Number: 15929399
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)220407
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: M271620
• 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: 07/29/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown