MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35 X PROFLEXX

Model Number	0015710
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported while attempting to load a patient, the patient shifted their weight causing the stretcher to allegedly tip to the right side.It was reported the patient remained on the stretcher and never made contact with the ground.The patient complained of knee pain alleged from pressure against the restraint.No further details were provided.
Additional Manufacturer Narrative
The cot was returned to the manufacturer for evaluation.A visual and functional evaluation was conducted; however, there were no observations of anything which would contribute to the cot tipping to the side while being loaded.The cot was functioning according to specification.No additional details were provided regarding the alleged patient injury.The complainant originally reported the patient shifted their weight during the loading process and it has been determined this was the contributing factor to the reported incident.The ifu for the cot provides sufficient instructions on the proper restraining of a patient to reduce movement as well as guidance on the required operators and their positions necessary for the loading process to ensure control of the cot throughout the process.
Event or Problem Description
The complainant reported while attempting to load a patient, the patient shifted their weight causing the stretcher to allegedly tip to the right side.It was reported the patient remained on the stretcher and never made contact with the ground.The patient complained of knee pain alleged from pressure against the restraint.No further details were provided.

• Brand Name: 35 X PROFLEXX
• Common Device Name: 35 X PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 7113017
• Report Number: 1523574-2017-00056
• Device Sequence Number: 1874365
• Product Code: FPO
• UDI-Device Identifier: 00190790000332
• UDI-Public: 00190790000332
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Emergency Medical Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: Emergency Medical Technician
• Device Model Number: 0015710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/22/2018
• 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
• Patient Age: 60 YR