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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stretcher was returned to the manufacturer for a functional and visual evaluation.The reported issue with the touchpads could not be duplicated and the buttons were operating as intended.Additionally, the stability of the stretcher was tested with 400lbs and the stretcher did not tip and all four wheels remained on the ground.Due to the nature of the incident and the age of the stretcher, the touchpads were replaced as a preventive measure and the stretcher was returned to the customer.It is suspected the nature of the medical activities being performed during and after the unloading of the stretcher may have unintentionally contributed to the shift in the stretcher's center of gravity resulting in the tip.
Event or Problem Description
It was reported after unloading an emergent patient from the ambulance at the hospital, the buttons did not function to lower the stretcher to a lowered transport height.At the time a medic was on the stretcher with the patient performing chest compressions.The crew began turning the stretcher, with the medic and patient, at the loading height and the weight of the stretcher began shifting to the patients right and the stretcher tipped to the ground.The medic did not report any injury as a result of the tip.The patient remained restrained to the stretcher but was observed to have sustained a laceration above the left eye.The patient was removed from the stretcher restraints and chest compressions resumed until hospital staff took over the patient care.No additional information was provided on the outcome of the patient.

• 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: 22388376
• Report Number: 1523574-2025-00070
• Device Sequence Number: 17887210
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)200806
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/13/2025

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: M675140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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: Male
• Patient Weight: 159 KG