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	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results of investigation: vyaire medical was able to verify the customer's reported issue during the initial final test.The unit failed the minimum power source test due to the alarming of "hardware fault 18 & hardware fault 20".Bench testing determined that the reported problem was due to a non-conforming hybrid board.Vyaire medical replaced the hybrid board and transferred the defective hybrid board to our failure analysis lab.Failure analysis results: vyaire medical installed the defective component into a known good ptv test unit and powered it on into "user mode".Power up was successful and the unit operated for approximately 6 minutes of cycling on the default settings when the unit alarmed "hw fault 20" (primary alarm ultra cap fault) appeared and the unit went inoperable.This reported issue was isolated to the capacitor.
Event or Problem Description
It was reported to vyaire medical that the ventilator was alarming hw fault 20, there was no report of any patient involvement associated with this reported event.

• 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: 8702283
• Report Number: 2031702-2019-03254
• Device Sequence Number: 1748175
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20111201
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/15/2019

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: 03/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 06/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1