MAUDE Adverse Event Report: VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	ENVE VENTILATOR
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.
Event or Problem Description
It was reported to vyaire that the enve ventilator had smoke coming out of the unit while connected to a patient.The customer confirmed that there was no patient harm associated with the reported incident.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8529264
• Report Number: 2031702-2019-03217
• Device Sequence Number: 1928588
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20110308
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070594
• 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): 03/21/2019

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: ENVE VENTILATOR
• Device Catalogue Number: 19250-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1