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

Model Number	0015803
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading a patient from the ambulance the patient reached their arms outward from the stretcher when the stretcher bumped against the sill of the floor.The patient's movement initiated a tilting motion and the crew was unable to stop the tipover of the stretcher.The patient remained restrained to stretcher but allegedly sustained abrasions as a result of the tipover.The patient also alleged striking their head during the fall.The patient was evaluated in the er.Additional details of the alleged injuries or required medical intervention have not been provided.
Additional Manufacturer Narrative
An authorized field technician was dispatched to evaluate the stretcher at the complainant's site.A visual and functional evaluation was conducted and there were no observations of anything that would have contributed to the cot tipping to the side.Unrelated observations were made.The stretcher was returned to manufacturer for necessary and recommended repairs.The sudden movement of the patient has been determined to be the contributing factor to the incident.The complainant stated during the transport the patient had been told multiiple times to not reach their arms outward from the stretcher.The ifu contains sufficient instructions for unloading a patient on the cot as well as the importance of maintaining control of the movement of the stretcher when transporting a patient.No additional information has been provided regarding the patient's alleged injuries.
Event or Problem Description
It was reported while unloading a patient from the ambulance the patient reached their arms outward from the stretcher when the stretcher bumped against the sill of the floor.The patient's movement initiated a tilting motion and the crew was unable to stop the tipover of the stretcher.The patient remained restrained to stretcher but allegedly sustained abraisions as a result of the tipover.The patient also alleged striking their head during the fall.The patient was evaluated in the er.Additional details of the alleged injuries or required medical intervention 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: 8420596
• Report Number: 1523574-2019-00012
• Device Sequence Number: 2327495
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/03/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: 230