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

Model Number	REVEL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H10:the suspect device has been returned for evaluation.Factory service technician was able to verify the reported issue during bench testing.Event trace download and initial final test could not be performed due to the vent failing to power up.Further investigation revealed a non-conforming hybrid board that was causing the vent inop erable issue and the unit not powering up.A known good hybrid board was installed and the reported issue was resolved.The reason behind the hybrid board failing could not be determined during testing at service, the hybrid board will be sent to fa (failure analysis) lab for further testing and analysis.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that ventilator inoperable alarm occurred on the revel ventilator.The customer reported there was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h6 & h10 results of investigation: vyaire medical received the device for evaluation.Visual inspection of the uut (unit under test) found no abnormalities.Installed the uut onto a known good ptv test vent.Performed post (power on self-test) in start-up mode per service manual, ptv ventilators failed the post and would not power up.Further troubleshooting and reviewing schematic document 19572-001 found q602 to have an internal failure which is the cause of no power.Q602 is part of the external power source electrical pathway.Factory technician findings and the reported complaint were verified and confirmed.The hybrid board q602 component has an internal failure that causes no power.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18630336
• Report Number: 2021710-2024-18724
• Device Sequence Number: 7955011
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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: REVEL
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown