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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported while transporting a (b)(6) patient at the lowest level and aligning the stretcher with the ambulance, the medics heard a cracking sound and noticed the cot leaning to the right.No injuries were reported, as a result; however, the crew did transfer the patient to another stretcher to complete the transport.
Additional Manufacturer Narrative
The device was returned to ferno for a full evaluation and a visual and functional evaluation was conducted.There were multiple impact marks to the lower legs which appear to have occured prior to the incident.The root cause appears to be caused by possible fatigue at the leg slider due to consistant impacts to the legs.The unit was repaired by ferno and returned to the customer.No further details have been provided.
Event or Problem Description
The complainant reported while transporting a 680 lb patient at the lowest level and aligning the stretcher with the ambulance, the medics heard a cracking sound and noticed the cot leaning to the right.No injuries were reported, as a result; however, the crew did transfer the patient to another stretcher to complete the transport.

• 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: 11530038
• Report Number: 1523574-2021-00003
• Device Sequence Number: 4881774
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/04/2021

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: 03/23/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/04/2021
• 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: 308