MAUDE Adverse Event Report: VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

Model Number	ENVE VENTILATOR
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire complaint number: (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 experienced screen issues.The screen is showing wavy lines throughout the display.At this time, it is unknown if there was any patient involvement associated with the reported issue.
Additional Manufacturer Narrative
Results of investigation: a vyaire failure analysis lab technician was able to verify the customer's reported issue.Bench testing revealed was due to lcd board to lcd panel cable assembly not properly attached to cn1 of the lcd panel.Service tech re-attached the cable assembly and the reported issue was resolved, vent passed initial final test for troubleshooting with no issue.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 9662252
• Report Number: 2031702-2020-03391
• Device Sequence Number: 19746411
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20110916
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K070594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1