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

Model Number	0015700
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2016
Event or Problem Description
It was reported while unloading the patient and stretcher from the ambulance the medics allege they heard a loud pop when lowering the wheels and the cot allegedly came out of the ambulance and collapsed.The medic crew was able to catch the stretcher before it lowered to the ground or tipped over.The patient was checked for injuries and the stretcher was placed into position and the transport continued.Once in the hospital an rn was advised of the incident and the cot was removed from service on arrival back to the station.An investigation has been initiated to evaluate the stretcher and the details of the reported incident.No related injuries have been reported to date.
Additional Manufacturer Narrative
The cot was evaluated at the complainant's site.A visual and functional evaluation was conducted.The reported issue could not be duplicated and the cot was operating according to specification.Other maintenance issues were noted at the time of evaluation and were repaired; however, these were not contributing factors to the reported incident.It could not be determined what made the reported "popping" noise or what caused the alleged collapse.The user manual provides instruction and multiple cautions for the user to verify the locked position of the cot before moving it.No new information has been received indicating the patient was injured or otherwise adversely affected by the incident.
Event or Problem Description
It was reported while unloading the patient and stretcher from the ambulance the medics allege they heard a loud pop when lowering the wheels and the cot allegedly came out of the ambulance and collapsed.The medic crew was able to catch the stretcher before it lowered to the ground or tipped over.The patient was checked for injuries and the stretcher was placed into position and the transport continued.Once in the hospital a rn was advised of the incident and the cot was removed from service on arrival back to the station.An investigation has been initiated to evaluate the stretcher and the details of the reported incident.No related injuries have been reported to date.

• 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: 6190239
• Report Number: 1523574-2016-00036
• Device Sequence Number: 11001825
• Product Code: FPO
• UDI-Device Identifier: 00190790000318
• UDI-Public: 00190790000318
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/30/2017

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: 0015700
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 01/31/2017
• 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: 113