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

Model Number	ENVE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical complaint number: (b)(4).At this time, vyaire medical is in the process of examining the suspect device.Once evaluated, a follow-up medwatch report will be submitted.
Event or Problem Description
It was reported to vyaire medical that the touchscreen was frozen and will not respond.There was no report of any patient involvement associated with this reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was not able to duplicate the customer's reported issue during testing and evaluation.The ventilator passed 65.9 hours of extended testings without any unusual alarm or error condition.Touchscreen calibration was performed several times and the ventilator passed.The ventilator passed the initial final test and the initial alarm volume test with no abnormalities.The ventilator was also opened up and inspected, and no anomalies were found.This ventilator meet all factory specifications.

• 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: 8306834
• Report Number: 2031702-2019-03147
• Device Sequence Number: 18843813
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20140813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/05/2019

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: ENVE
• Device Catalogue Number: 19250-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1