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

Model Number	0015811
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading a patient from the ambulance the guide wheels on the stretcher came out of the track and rolled onto the top of the fastener which did not allow the second safety bail to engage with the hook and the head end of the stretcher lowered from the ambulance.The stretcher remained upright and the patient denied any injury; however, a medic did allege a hand injury in the form of an abrasion but no medical intervention was sought.
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation at the customer's location.The stretcher was found to be operating as intended and the reported issue could not be duplicated.
Event or Problem Description
It was reported while unloading a patient from the ambulance the guide wheels on the stretcher came out of the track and rolled onto the top of the fastener which did not allow the second safety bail to engage with the hook and the head end of the stretcher lowered from the ambulance.The stretcher remained upright and the patient denied any injury; however, a medic did allege a hand injury in fhe form of an abrasion but no medical intervention was sought.

• 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: 19217718
• Report Number: 1523574-2024-00039
• Device Sequence Number: 8198489
• 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,Followup
• Report Date (Section B): 08/06/2024

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
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 73 KG