MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW; ENFLOW¿ IV FLUID/BLOOD WARMER MODEL 100

Model Number	980105VS
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device for evaluation.The customer reported being unable to confirm the serial number of the device at this time.Any additional information received from the customer or through vyaire's internal investigation will be included in a follow-up report.
Event or Problem Description
The customer reported while using the enflow device, the cardiac electrocardiogram (ecg) displayed interference.The anesthesiologist witnessed when the enflow machine was turned on.The customer reported the case was cancelled and the patient was ordered a 12-lead ecg, which came back normal.The customer reported a delay in treatment and reported there is no patient consequence associated with the event.

• Brand Name: ENFLOW
• Common Device Name: ENFLOW¿ IV FLUID/BLOOD WARMER MODEL 100
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8536418
• Report Number: 3008959444-2019-00009
• Device Sequence Number: 11370319
• Product Code: LGZ
• UDI-Device Identifier: 10885403296789
• UDI-Public: (01)10885403296789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 980105VS
• Device Catalogue Number: 980105VS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/22/2019
• 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: Required Intervention