MAUDE Adverse Event Report: VYAIRE MEDICAL INC ASSY,LTV1200,W/ACC.ENGLISH,MR COND; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18888-201
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.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 customer reported low o2 press alarm while vent was on patient.The customer reported that patient desaturated but was not injured.
Additional Manufacturer Narrative
Device evaluation: d9, g3, g6, h2, h3, h6 and h11.Result of investigation: failure analysis was able to confirm but was unable to duplicate the reported problem.Unit passed all testing.Performed 6 year pm maintenance.

• Brand Name: ASSY,LTV1200,W/ACC.ENGLISH,MR COND
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 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 ; 8478865998
• MDR Report Key: 19629676
• Report Number: 3013421741-2024-00230
• Device Sequence Number: 7093442
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101463
• 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,Followup
• Report Date (Section B): 06/27/2024

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: Other
• Device Model Number: 18888-201
• Device Catalogue Number: 18888-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2017
• 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