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

Model Number	0015710
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while loading the cot into the ambulance the legs of the cot allegedly became locked and were unable to be lifted.There were no reports of a delay in transfer or injury to the patient; however, a medic has alleged a forearm injury as a result of the incident.The initial report states the medic sought treatment in the er; however, no details of the nature of the treatment or the severity of the alleged injury were provided.
Additional Manufacturer Narrative
The cot was returned to ferno and a visual and functional test was conducted.This was a 9yr old cot in fair condition and in need of repair.It was found the screw connecting the two operator handles on the release system was missing.Without this hardware the release handle will not operate properly.The user manual for the product provides preventative maintenance instructions for review of loose and missing hardware.No authorization was given to repair.The cot was returned to complainant.The complainant could not provide any further information regarding the emt's allegation of injury.
Event or Problem Description
It was reported while loading the cot into the ambulance the legs of the cot allegedly became locked and were unable to be lifted.There were no reports of a delay in transfer or injury to the patient; however, a medic has alleged a forearm injury as a result of the incident.The initial report states the medic sought treatment in the er; however, no details of the nature of the treatment or the severity of the alleged injury were provided.

• 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: 6452984
• Report Number: 1523574-2017-00011
• Device Sequence Number: 462122
• 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): 05/11/2017

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: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/11/2017
• 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