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

Model Number REVEL, GRN, DISS, ENGL

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: M2M ASSY, PKG, REVEL, GRN, DISS, ENGL
• Type of Device: 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
• MDR Text Key: 341261453
• Report Number: 2021710-2024-19049
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029(11)20210331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1