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

Model Number	0015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	04/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while removing a patient from the ambulance the undercarriage of the cot would allegedly not lower.While trying to lower the undercarriage, the patient's weight shifted causing the cot to tip over onto the ground.The patient claimed no injury after the incident.Both crew members alleged injury to their lower back and legs and were seen at the er.No further details of the incident or alleged injuries have been received.
Additional Manufacturer Narrative
The cot was returned to manufacturer for evaluation.A visual and functional evaluation was conducted.The overall condition of the cot was consistent with the age of the cot (8+ years) and exhibited signs of extensive use.The cot operated as intended throughout the function test and the undercarriage released without difficulty when supported by the second operator.The alleged issue could not be duplicated.No further information was provided regarding the alleged medic injuries or the later alleged injury by the patient.
Event or Problem Description
It was reported while removing a patient from the ambulance the undercarriage of the cot would allegedly not lower.While trying to lower the undercarriage, the patient's weight shifted causing the cot to tip over onto the ground.The patient claimed no injury after the incident.Both crew members alleged injury to their lower back and legs and were seen at the er.No further details of the incident or alleged injuries have been received.

• Brand Name: 35X PROFLEXX X-FRAME COT
• Common Device Name: 35X PROFLEXX X-FRAME COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6502984
• Report Number: 1523574-2017-00015
• Device Sequence Number: 11954
• 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): 07/10/2017

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: 04/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 07/10/2017
• 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