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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Abrasion (1689); Skin Tears (2516)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading a patient from the ambulance, the head end safety bail allegedly did not engage with the hook and the cot came out of the truck and tipped to the patient right.The patient denied injury; however, several skin tears and abrasions were observed from the patient making contact with the asphalt.Details of required medical intervention were not provided.
Additional Manufacturer Narrative
An authorized field technician was dispatched to evaluate the cot at the complainant's location.A visual and functional evaluation was conducted and the cot was found to be operating according to specifications and no malfunctions were detected.It was observed the catch bar was sprung forward a little bit but not enough to miss the safety hook.The cot was cycled in and out of the ambulance multiple times and the bar engaged with the hook each time.The complainant also advised they were unable to duplicate the incident.The ifu for the product contains clear instructions on unloading the cot with a patient and ensuring engagement with the safety hook prior to pulling the cot from the ambulance.No further communication has been received regarding the alleged patient injury and medical intervention.
Event or Problem Description
It was reported while unloading a patient from the ambulance, the head end safety bail allegedly did not engage with the hook and the cot came out of the truck and tipped to the patient right.The patient denied injury; however, several skin tears and abrasions were observed from the patient making contact with the asphalt.Details of required medical intervention were not provided.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 7902773
• Report Number: 1523574-2018-00033
• Device Sequence Number: 1692913
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 45