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

Model Number	0015803
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while on scene for a transport, the stretcher would allegedly not raise or lower using the power feature.The medic team made the decision to transfer the patient care to another crew.It was confirmed the manual release did function as intended but was not utilized to continue the transport.There have been no reports of adverse effect to the patient as a result of the incident.
Additional Manufacturer Narrative
The stretcher was returned to the manufacturer.A visual and functional evaluation was conducted by a quality technician.The reported issue could not be duplicated; however, possible damage to a sensor was observed which could have potentially caused the intermittent error reported by the complainant.This sensor was replaced and the stretcher was returned to the complainant.No additional information regarding the incident was provided by the complainant.The ifu contains instructions for troubleshooting the reported error message as well as the availability of a manual operation system to maintain the intended use of the cot.
Event or Problem Description
It was reported while on scene for a transport, the stretcher would allegedly not raise or lower using the power feature.The medic team made the decision to transfer the patient care to another crew.It was confirmed the manual release did function as intended but was not utilized to continue the transport.There have been no reports of adverse effect 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: 9141602
• Report Number: 1523574-2019-00032
• Device Sequence Number: 16612737
• 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): 10/30/2019

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: 10/09/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1