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

Model Number	0015693
Health Effect - Clinical Codes	Abrasion (1689); Fall (1848)
Date of Event	09/20/2016
Event or Problem Description
It was reported while rolling the cot along a sidewalk at a retail location, one of the rear wheels of the cot allegedly became detached causing the cot to tip with a patient on board.No medics were injured; however, it was reported the patient allegedly sustained an abrasion to the arm.The transport was able to be completed with no delay.The er staff at the hospital was advised of the incident and the alleged injury; however, no further information was provided indicating any need for treatment of the alleged injury.An investigation has been initiated to evaluate the reported incident.
Additional Manufacturer Narrative
The device was evaluated by a field technician at the complainant's site.A visual and functional evaluation was conducted.The technician confirmed the left side wheel assembly had fallen off the cot.The technician also observed other maintenance issues at the head end of the cot.The cot was repaired and tested with 150 lbs and found all functions were working correctly and the unit was returned to service.The cot was 6+ years old at the time of incident and the last documented maintenance on the cot was july 2015.It could not be determined what caused the wheel assembly to detach from the unit.No further information was provided from the complainant indicating additional injuries or medical intervention was required to prevent the patient's alleged abrasion from becoming a serious injury.
Event or Problem Description
It was reported while rolling the cot along a sidewalk at a retail location, one of the rear wheels of the cot allegedly became detached causing the cot to tip with a patient on board.No medics were injured; however, it was reported the patient allegedly sustained an abrasion to the arm.The transport was able to be completed with no delay.The er staff at the hospital was advised of the incident and the alleged injury;however, no further information was provided indicating any need for treatment of the alleged injury.An investigation has been initiated to evaluate the reported incident.

• Brand Name: 35X PROFLEXX
• Common Device Name: 35X PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 5990673
• Report Number: 1523574-2016-00028
• Device Sequence Number: 13462636
• Product Code: FPO
• UDI-Device Identifier: 00190790000301
• UDI-Public: 00190790000301
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/09/2016

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: 0015693
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 12/09/2016
• 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: 75