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 Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the cot in manual mode, due to an uncharged battery, the medic crew was "allegeldy" unable to lower the legs of the stretcher.A backup unit was called to continue the patient transport.No injuries or adverse effects to the patient or crew were reported as a result of the incident.
Event or Problem Description
It was reported while using the cot in manual mode, due to an uncharged battery, the medic crew was allegeldy unable to lower the legs of the stretcher.A backup unit was called to continue the patient transport.No injuries or adverse effects to the patient or crew were reported as a result of the incident.
Additional Manufacturer Narrative
An authorized field technician was dispatched to evaluate the stretcher at the complainant's location.A visual and functional evaluation was conducted and it was determined the battery failure was due to a kinked ics wire near the connection with the floor cable allowing for intermittant charging of the battery.The ics wire was replaced and the unit was verified to be charging as intended.The manual release system of the stretcher was also evaluated and was found to be operating as intended.The alleged issue of the manual release not working could not be duplicated.No additional information has been provided regarding any later alleged adverse effects to the patient as a result 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: 8221880
• Report Number: 1523574-2018-00042
• Device Sequence Number: 16621948
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/12/2019

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: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1