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

Model Number	KIT,SIPAP,IF,PLUS,AUX,MDISS,ENGLISH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - the customer reported that they will not return the defective unit/part for evaluation.Therefore, no root cause could be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device will not be returned.
Event or Problem Description
It was reported to vyaire medical problem with the sipap ventilator in which the end users are reporting that when they powered on the device, the screen 'went blank.'.Furthermore, there was no patient associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was unable to verify the customer complaint.The suspect device was returned for investigation.Vyaire received assembly, battery, mk3 part number: 16387 lot code: 030123-ld.Visually inspected on uut (unit under test) assembly, there was no visible defect, contamination, or any damaged.The uut was installed into a known good sipap test vent.Powered the uut without ac connected and the screen appeared in diagnosis mode.Cycled on/off multiple times and no alarm errors appeared on screen.Allowed the battery to charge for a period of 18 hours, measured voltage output.The reported complaint was not confirmed or duplicated.The uut was below voltages specifications and can be determined by the supplier if a trend is identified.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 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 ; 8477865998
• MDR Report Key: 19041507
• Report Number: 2021710-2024-18966
• Device Sequence Number: 7241975
• Product Code: CBK
• UDI-Device Identifier: 10846446063486
• UDI-Public: (01)10846446063486
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 04/04/2024

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: KIT,SIPAP,IF,PLUS,AUX,MDISS,ENGLISH
• Device Catalogue Number: 27416-001
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 09/09/2024
• 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