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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while rolling a patient on the cot, the medic realized the cot was rolling too fast and the medic was unable to maintain control of the cot.The cot was rolling down an incline and began to turn when it hit the curb and allegedly tipped over.The patient complained of right shoulder pain and was evaluated at the hospital but was later discharged.Details of any required medical treatment were not provided.
Event or Problem Description
It was reported while rolling a patient on the cot, the medic realized the cot was rolling too fast and the medic was unable to maintain control of the cot.The cot was rolling down an incline and began to turn when it hit the curb and allegedly tipped over.The patient complained of right shoulder pain and was evaluated at the hospital but was later discharged.Details of any required medical treatment 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 nothing was found that would have contributed to the cot tipping over; however, the damaged observed, as a result of the reported incident was the telescoping handle on the cot would not telescope back in due to a dent on the tube.A decision was made to return the cot to ferno for further evaluation and repair of the handle.The telescoping handle and sleeve were replaced and the cot was returned to the customer.No additional reports were provided regarding the alleged patient injury.The ifu for the product contains sufficient warnings and instruction on maintaining control of the cot while transporting a patient.

• 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: 7654575
• Report Number: 1523574-2018-00027
• Device Sequence Number: 163525
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/22/2018

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: Emergency Medical Technician
• Device Model Number: 0015803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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 Age: 41 YR
• Patient Weight: 59