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

Model Number	0015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2016
Event or Problem Description
It was reported the cot and patient were unloaded from an ambulance and when the legs of the cot were released down, upon further exit, the cot allegedly collapsed causing the cot to strike the emt in both of his legs.The patient was not injured; however, the provided incident report indicated the medic sought medical treatment at the er.No details were provided regarding the alleged injury or the required medical treatment.
Additional Manufacturer Narrative
The cot was returned to the manufacturer for evaluation.A visual and functional evaluation was conducted and the reported issue could not be duplicated during testing.Each cycle the cot was put through the legs dropped and locked into place every time with no obstructions, both with and without weight applied.The overall condition of the cot was found to be fair with a couple of areas observed of needing repair.These areas were not contributing factors to the reported incident.The only way to duplicate the incident was to hold in on the release handle, creating an unlocked state.It could not be determined if this action was being done by the user at the time of incident.The complainant has not reported any further information regarding the alleged medic injury, the type of medical treatment sought or any later allegations of adverse effects to the patient.
Event or Problem Description
It was reported the cot and patient were unloaded from an ambulance and when the legs of the cot were released down, upon further exit, the cot allegedly collapsed causing the cot to strike the emt in both of his legs.The patient was not injured; however, the provided incident report indicated the medic sought medical treatment at the er.No details were provided regarding the alleged injury or the required medical treatment.

• 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: 6220149
• Report Number: 1523574-2017-00001
• Device Sequence Number: 928434
• 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): 02/07/2017

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: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/07/2017
• 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