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

Model Number	0015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Fall (1848)
Date of Event	05/20/2018
Type of Reportable Event	Death
Event or Problem Description
It was reported while loading a patient onto the cot, the mattress allegedly slid and the patient slid to the ground.The patient was placed back onto the cot without further incident.The cot was approximately at mid thigh level when the patient was being loaded.It was stated the patient passed away; however, the patient's condition prior to the alleged incident was reported as traumatic cardiac arrest.
Additional Manufacturer Narrative
The cot was returned to manufacturer for evaluation.A visual and functional evaluation was conducted by a quality engineer and it was determined the cot was functioning as intended with no observed malfunctions.It was confirmed the mattress being used did not have mattress clips; however, the mattress should still remain in position on the cot due to the sidearms, the restraints and the mattress stop at the foot end of the cot.Details of the activities occurring during the loading process were not provided; therefore, a determination of a contributing factor to the incident could not be identified.The complainant did confirm the police were doing cpr on the patient prior to the arrival of the ems crew indicating the patient was in cardiac arrest prior to the reported incident.Instructions are provided in the ifu on proper technique in transferring a patient onto the cot.
Event or Problem Description
It was reported while loading a patient onto the cot, the mattress allegedly slid and the patient slid to the ground.The patient was placed back onto the cot without further incident.The cot was approximately at mid thigh level when the patient was being loaded.It was stated the patient passed away; however, the patient's condition prior to the alleged incident was reported as traumatic cardiac arrest.

• Brand Name: 35X PROFLEXX
• Common Device Name: 35X PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 7548560
• Report Number: 1523574-2018-00022
• Device Sequence Number: 1813698
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 06/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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: Death
• Patient Age: 25 YR