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

Model Number	0015803
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while on a call the legs of the stretcher would allegedly not operate using power.The manual release was confirmed to be operational; however, the medics called a 2nd truck to continue the patient transport on another stretcher.No injury or adverse effect was reported as a result.
Event or Problem Description
It was reported while on a call the legs of the stretcher would allegedly not operate using power.The manual release was confirmed to be operational; however, the medics called a 2nd truck to continue the patient transport on another stretcher.No injury or adverse effect was reported as a result.
Additional Manufacturer Narrative
The stretcher was returned to manufacturer and a visual and functional evaluation was conducted by quality personnel.The reported issue was confirmed and traced back to the actuator not functioning properly.The actuator on the stretcher was replaced and the unit was returned to complainant.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh
• MDR Report Key: 10001039
• Report Number: 1523574-2020-00010
• Device Sequence Number: 16826387
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• 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): 05/27/2020

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: 04/30/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1