MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW; WARMER, THERMAL, INFUSION FLUID

Model Number	ENFLOW¿ CONTROLLER MODEL 121
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determine yet.(b)(4).Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that a burnt smell was noticed on the enflow control unit.There is no patient involvement associated in this event.

• Brand Name: ENFLOW
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9475113
• Report Number: 3008959444-2019-00010
• Device Sequence Number: 2258654
• Product Code: LGZ
• UDI-Device Identifier: 10885403296819
• UDI-Public: (01)10885403296819
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENFLOW¿ CONTROLLER MODEL 121
• Device Catalogue Number: 980121EU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1