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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported while loading a patient into the ambulance, the crew was having difficulties locking the stretcher into the fastener.It was decided to unload the stretcher from the ambulance to better assess the situation.After lowering both sets of legs to the ground and releasing the stretcher from the safety bail, the head end of the stretcher lowered unexpectedly.The stretcher was then lowered to its lowest position and the patient was assessed.The patient was not injured as a result; however, a backup ambulance was called to complete the transport on another stretcher.Afterward it was discovered the manual release cable had come loose and was being pinched by the actuator movement resulting in the unintended movement and inhibiting the ability of the legs to fully retract for locking into the fastener.A video conference was held with manufacturer's technical support team and the reported issue was confirmed.The technical support team provided instructions on how to properly route the manual release cable to keep it from pushing into the actuator during operation.A replacement manual release cable was provided to the customer.

• 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: 24446539
• Report Number: 1523574-2026-00021
• Device Sequence Number: 10364211
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)230216
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 02/25/2026

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: M541350
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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: Female
• Patient Weight: 181 KG