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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cot was evaluated by an authorized service technician at the customer's location.A visual and functional evaluation was conducted and the cot was found to be functioning as intended.The ifu contains sufficient instructions for safe unloading of the stretcher from the ambulance.The cot was function tested and returned to service.No further details were provided pertaining to the alleged patient's injury.
Event or Problem Description
It was reported while unloading a patient from the ambulance the stretcher allegedly missed the safety hook and the head end of the stretcher came out of the truck before the head end legs were lowered.The patient allegedly injured their left arm as a result and received medical intervention at the hospital, including xrays.Additional details on the alleged injury and the results of the xrays have not been 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: 9168363
• Report Number: 1523574-2019-00034
• Device Sequence Number: 11500621
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/08/2019
• 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: 113