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	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while unloading the patient from the ambulance the medic at the head end of the stretcher allegedly released the stretcher from the safety hook prior to the foot end medic fully lowering the head end legs and the stretcher rolled off the deck of the ambulance and tipped.The patient allegedly sustained an abrasion to the left elbow and complained of arm and lower back pain.The patient was evaluated at the hospital but no further details were provided.
Additional Manufacturer Narrative
An authorized field technician was dispatched to conduct a visual and functional evaluation at the customer's location.There was no observation of structural damage to the stretcher and it was operating as intended.The contributing factor to the incident is being associated with unintentional use error.
Event or Problem Description
It was reported while unloading the patient from the ambulance the medic at the head end of the stretcher allegedly released the stretcher from the safety hook prior to the foot end medic fully lowering the head end legs and the stretcher rolled off the deck of the ambulance and tipped.The patient allegedly sustained an abrasion to the left elbow and complained of arm and lower back pain.The patient was evaluated at the hospital but no further details were provided.

• 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 ; 9382832900
• MDR Report Key: 18267917
• Report Number: 1523574-2023-00042
• Device Sequence Number: 3956045
• Product Code: FPO
• UDI-Device Identifier: 00190790001339
• UDI-Public: (01)00190790001339(11)230224
• 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): 05/02/2024

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): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 127 KG