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

Model Number	0015788
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/04/2016
Additional Manufacturer Narrative
The cot was evaluated by a field technician at the complainant's site.A visual and functional evaluation was conducted and the cot was functioning according to specification.The release mechanism on this cot requires the cot to be lifted to remove the weight off the legs before the release mechanism will operate.It is suspected the operators were not taking all of the weight off the legs before activating the release mechanism.No further details have been provided regarding the medic's alleged injury, the type of medical treatment sought or the outcome of the medical treatment.
Event or Problem Description
It was reported while lifting the frame of the cot to release the locking mechanism, a medic allegedly injured their back when the mechanism would not release.There was a patient on the cot at the time of incident but there were no reports of injury or adverse consequence to the patient.The initial report of the incident indicated the medic did not seek medical intervention for the alleged injury but rather used ice and rest.It was later reported on 12/23/2016 that the medic was going to seek medical treatment for the alleged injury due to ongoing pain.

• Brand Name: 35X NM COT
• Common Device Name: 35X NM COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 6208287
• Report Number: 1523574-2016-00040
• Device Sequence Number: 862848
• Product Code: FPO
• UDI-Device Identifier: 00190790000349
• UDI-Public: 00190790000349
• 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
• Report Date (Section B): 12/23/2016

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: 0015788
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 12/28/2016
• 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: 84