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

Model Number	0015710
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	11/13/2016
Event or Problem Description
It was reported after removing the patient and cot from the ambulance the crew engaged the stretcher lock and then stepped away from the cot to turn the ambulance off.The stretcher lock allegedly disengaged and the stretcher began to roll.The emt attempted to control the stretcher but due to the patient's weight was unable to hold the stretcher and it tipped over with the patient.The patient was assessed and allegedly complained of pain to her left shoulder.The crew transported the patient into the hospital and alerted the receiving rn to the incident and allegation of pain.
Additional Manufacturer Narrative
The cot was returned to manufacturer and a visual and functional evaluation was conducted.The overall condition of the cot was very good and showed signs of very little use.The wheel locks on the cot were cycled with no malfunctions or other issues detected.When the brakes were engaged they were all the way locked and there were no worn areas that would allow a partial lock.The ifu for the cot provides instruction on engaging the locks as well as not leaving the cot unattended when a patient is loaded.Upon review of the investigation, it appears the medic left the cot unattended and then could not maintain control of the cot when it started to roll.It could not be determined if the brake was completely engaged at the time of incident.The complainant did not have any additional information regarding alleged injury or medical intervention for the patient.
Event or Problem Description
It was reported after removing the patient and cot from the ambulance the crew engaged the stretcher lock and then stepped away from the cot to turn the ambulance off.The stretcher lock allegedly disengaged and the stretcher began to roll.The emt attempted to control the stretcher but due to the patient's weight was unable to hold the stretcher and it tipped over with the patient.The patient was assessed and allegedly complained of pain to her left shoulder.The crew transported the patient into the hospital and alerted the receiving rn to the incident and allegation of pain.

• 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: 6132487
• Report Number: 1523574-2016-00035
• Device Sequence Number: 13611238
• 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): 01/30/2017

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: 0015710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• 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