MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100A HFOV; VENTILATOR, HIGH FREQUENCY

Model Number	768901
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that during use on a patient, the device shut down.Complainant indicated that there was no adverse effect to the patient due to the reported issue.
Additional Manufacturer Narrative
D4: udi #: the complete udi number is unknown as it was not provided by the reporter.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
H3: the device was not returned for physical evaluation.Technical support worked with the biomedical engineer at the hospital.Upon inspection by the biomed, water was found in the pressure sensing line connected to the pressure transducer.This moisture intrusion likely caused damage to the transducer, resulting in erratic pressure signals and failed calibrations.The instability may have contributed to the driver shutting down unexpectedly.It is recommended that the pressure transducer and airway pressure tubing be replaced to resolve the issue.G1: contact information has been updated.

• Brand Name: 3100A HFOV
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd; mettawa IL 60045
• Manufacturer Contact: mindy faber ; 1100 bird center dr.; palm springs, CA 92262 ; 8333273284
• MDR Report Key: 21874473
• Report Number: 3013421741-2025-01545
• Device Sequence Number: 8640970
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

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: Other
• Device Model Number: 768901
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown