MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 93H PROFLEXX AMBULANCE COT

Model Number	0015762
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/06/2016
Event or Problem Description
It was reported while transporting a (b)(6) patient on the stretcher, the stretcher hit a small bump on the residents dark pathway and the cot allegedly lowered approximately 12 inches.There was no report of any injury to the patient; however, an emt is alleging a shoulder injury.The complainant was contacted and it was reported the medic sought basic first aid for the alleged injury.An investigation has been initiated to evaluated 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 and no issues or problems were detected and the cot was operating according to specification.The cot was tested and returned to service.No further information regarding the medic's alleged injury has been provided.It cannot be determined if the alleged injury was serious in nature.
Event or Problem Description
It was reported while transporting a 300-400lb patient on the stretcher, the stretcher hit a small bump on the residents dark pathway and the cot allegedly lowered approximately 12 inches.There was no report of any injury to the patient; however, an emt is alleging a shoulder injury.The complainant was contacted and it was reported the medic sought basic first aid for the alleged injury.An investigation has been initiated to evaluated the reported incident.

• Brand Name: 93H PROFLEXX AMBULANCE COT
• Common Device Name: 93H PROFLEXX AMBULANCE COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6130534
• Report Number: 1523574-2016-00031
• Device Sequence Number: 19029355
• Product Code: FPO
• UDI-Device Identifier: 00190790000417
• UDI-Public: 00190790000417
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/16/2016

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: 0015762
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 12/16/2016
• 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: 181