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

Model Number	0015803
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while unloading the empty cot, the first release bar allegedly did not catch the hook and the cot began to come out of the ambulance.The medic had to assume the weight of the cot until additional assistance arrived and is alleging lower back pain; however no medical intervention was sought.It was reported the same incident occurred later in the day with another medic but no allegation of injury was reported in that instance.
Additional Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainant's site.A visual and functional evaluation was conducted.The cot was loaded and unloaded from the ambulance multiple times and the cot engaged with the safety hook each time.The reported issue could not be duplicated.The ifu provides clear instruction on unloading the cot and verifying the cot has engaged with the safety hook prior to pulling the cot past the threshold.
Event or Problem Description
It was reported while unloading the empty cot, the first release bar allegedly did not catch the hook and the cot began to come out of the ambulance.The medic had to assume the weight of the cot until additional assistance arrived and is alleging lower back pain; however, no medical intervention was sought.It was reported the same incident occurred later in the day with another medic but no allegation of injury was reported in that instance.

• 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: 7273043
• Report Number: 1523574-2018-00011
• Device Sequence Number: 1029463
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: Paramedic
• Device Model Number: 0015803
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 02/28/2018
• 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