MAUDE Adverse Event Report: VYAIRE MEDICAL M2M ASSY, PKG, REVEL, GRN, DISS, ENGL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	REVEL, GRN, DISS, ENGL
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that upon going to start up the vent it began beeping and vent inop light is seeing flashing red along with the control lock, manual breath, and maneuvers buttons all being lit up green.The vent cycled on twice with the led screen lighting up for a second but then shutting off (going blank) immediately after both times.No patient involvement, issue found during start-up.
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).H3: other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Device evaluation: finding/root-cause: reported complaint was verified and duplicated.This was isolated to capacitors p/n:13804-001 and has been addressed by capa-000000497.

• Brand Name: M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
• 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 ; 1100 bird center drive; palm springs, CA 92262 ; 2402760001
• MDR Report Key: 19169865
• Report Number: 2021710-2024-19049
• Device Sequence Number: 17974506
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029(11)20210331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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, GRN, DISS, ENGL
• Device Catalogue Number: 19260-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2021
• 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