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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Third party service technician was able to verify customer's reported problem display screen non responsive.Ventilator was tested with a known good ac adapter connected.Performed a display test, results were fail.Lower right section of lcd display would not respond to touch.Service technician installed new lcd display.The ventilator failed final test for non-conformance with measured o2 at pressure and o2 test 12.Measured o2 was 84.4, expected is 85.0 - 95.0.Service technician replaced flow sensor.The ventilator passed final assembly and close up.Display will be sent to vyaire failure analysis laboratory for root cause analysis.Vyaire medical will submit a supplemental report in accordance.
Event or Problem Description
The customer reported that the enve ventilator display screen is not responsive.There was no patient involvement associated with this event.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9982464
• Report Number: 2031702-2020-03458
• Device Sequence Number: 2092886
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20110916
• Combination Product (Y/N): N
• 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): 03/25/2020

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: ENVE VENTILATOR
• Device Catalogue Number: 19250-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1