MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	INFANT FLOW SIPAP CONFIGURATION
Medical Device Problem Codes	Mechanical Problem (1384); No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 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.
Event or Problem Description
It was reported to vyaire medical the infant flow sipap has not holding pressure during patient use.Furthermore, the patient was swapped in a different ventilator and there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Results of investigation:the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The uut was powered on in user mode with software version 2.09, and service manual: 23034-001 was performed.The uut failed the leak test at 3lpm pres high flow meter, indicating that the device was not holding pressure.No anomalies were discovered after disassembling the unit to verify the tubing and connectors.The fault issue persisted after installing a known good component; pressure pcba, sensor valve, and exhaust block assembly.The uut passed after installing a known good main pcba and performing a leak test chapter 6-operational verification test.The reported complaint was confirmed and duplicated.This is isolated to a faulty main pcba (printed circuit board assembly).
Additional Manufacturer Narrative
Results of investigation: the vyaire failure analysis laboratory received the pcba, main processor and performed a failure investigation.The uut was installed in a known good sipap test stand.Powered on user mode with software version 2.09, performed operational verification test, the uut was not holding pressure.Continuity test verified shorts between pins and proper voltage at vcc pins was not found.Uninstalled pcba main processor from sipap test stand and replaced ic op amp dual cmos r-r 8-soic location ic27.Installed pcba and powered on, performed leak test chapter 6-operational verification test, and the uut passed.The removed chip ic op amp dual cmos r-r 8-soic was placed under a microscope vhx-1 and no visual defects or damaged was found.The reported complaint was confirmed and duplicated.This is isolated to faulty ic (integrated circuit) op amp dual cmos r-r 8-soic.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north 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 ; 8477865998
• MDR Report Key: 18074685
• Report Number: 2021710-2023-18364
• Device Sequence Number: 15351862
• Product Code: CBK
• UDI-Device Identifier: 10846446063486
• UDI-Public: (01)10846446063486
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K031745
• 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,Followup
• Report Date (Section B): 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INFANT FLOW SIPAP CONFIGURATION
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 07/24/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/15/2023; 08/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown