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

Model Number	0015803
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported after loading a patient onto the cot, the cot would allegedly not raise or lower.It was later noticed the crossbar on the lower frame was broken.The patient was transported to a backup unit to complete the transport.There were no injuries or adverse effects as a result of the incident and the complainant reported they did not utilize the manual release function at the time of the incident.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the customer's location.A visual and functional evaluation was conducted.The technician confirmed the lower crossbar was damaged and in need of replacement.The alleged incident has been attributed to damages to the lower crossbar, however the circumstances leading up to the damage could not be confirmed.The technician noted there were no issues found on the cot that would have caused the crossbar to break.The stretcher was repaired and returned to service.No injuries have been reported, as a result of the incident.
Event or Problem Description
The complainant reported after loading a patient onto the cot, the cot would allegedly not raise or lower.It was later noticed the crossbar on the lower frame was broken.The patient was transported to a backup unit to complete the transport.There were no injuries or adverse effects as a result of the incident and the complainant reported they did not utilize the manual release function at the time of the incident.

• 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: 8907332
• Report Number: 1523574-2019-00028
• Device Sequence Number: 2001202
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/10/2019

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
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: 82