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

Model Number	0015710
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while on scene the crew was lifting the stretcher to the top level to drop the drag wheels so the stretcher would fit into the elevator.The crew alleges the patient shifted their weight causing the stretcher to tip over.No further details have been provided by the complainant regarding the alleged incident or the impact to the patient.
Additional Manufacturer Narrative
The subject cot was returned to manufacturer for evaluation.A visual and functional evaluation was conducted.The cot was found to be functioning as intended and the reported incident could not be duplicated.It was observed the cot did have a bent load end caster and a bolt was missing from the drop frame.Both maintenance observations were recommended to be fixed prior to return to service.No further information was provided regarding the patient's condition or further details of what occurred leading up to and during the incident.The ifu for the product provides clear instruction on transitioning the position of the cot and maintaining control of the cot while transporting a patient.
Event or Problem Description
It was reported while on scene the crew was lifting the stretcher to the top level to drop the drag wheels so the stretcher would fit into the elevator.The crew alleges the patient shifted their weight causing the stretcher to tip over.No further details have been provided by the complainant regarding the alleged incident or the impact to the patient.

• Brand Name: 35X PROFLEXX AMBULANCE COT
• Common Device Name: 35X PROFLEXX AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6395228
• Report Number: 1523574-2017-00009
• Device Sequence Number: 19015941
• 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): 03/28/2017

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: 03/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1