MAUDE Adverse Event Report: VYAIRE MEDICAL KIT,SIPAP,IF,PLUS,AUX,MDISS,ENGLISH; SIPAP VENTILATOR

Catalog Number	27416-001
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).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 that pre-use check was being ran, they were able to do the o2 calibration and it passed.After that the unit was "alarming" but not sure why or if there was an error code etc.Found that we have no history of a pm.No patient involvement.

• Brand Name: KIT,SIPAP,IF,PLUS,AUX,MDISS,ENGLISH
• Common Device Name: SIPAP VENTILATOR
• 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: 18949223
• Report Number: 2021710-2024-18913
• Device Sequence Number: 7348737
• Product Code: CBK
• UDI-Device Identifier: 10846446063486
• UDI-Public: (01)10846446063486
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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 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: 02/28/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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