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

Model Number	0015803
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Distress (2329)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading a 500+lb patient from the ambulance the battery died and the power feature of the stretcher could not be utilized.The medics had to call the fire department for assistance in completing the transport manually.There were no injuries associated with the incident; however, it was reported the patient did panic at the delay and the customer was upset.After the incident, the end user did confirm the stretcher operated properly when a new battery was installed.No evaluation was conducted and it is unknown if the end user completed a non-warranty evaluation with their service provider.

• 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: 22591793
• Report Number: 1523574-2025-00075
• Device Sequence Number: 21095545
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: (01)00190790000004(11)220422
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/24/2025

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: 0015803
• Device Catalogue Number: 0015803
• Device Lot Number: M293560
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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
• Patient Weight: 227 KG