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

Catalog Number	770155
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation update: vyaire medical's technician went on-site to evaluate the suspect device and could not duplicate the issue.Customer explained to the technician that previously they found the limit tube loose and tightened it but wanted verification.The technician calibrated airway pressure transducer, ddi and pneumatics.Also, ran performance check and the 3100b ventilator passed all test and runs according to oem specifications.
Event or Problem Description
It was reported to vyaire medical: the respiratory therapists reported fluctuating map and delta p while on patient.Patient harm or injury was not reported.

• Brand Name: 3100B HFOV
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• 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 ; 2402760001
• MDR Report Key: 19751128
• Report Number: 3013421741-2024-00276
• Device Sequence Number: 6606287
• Product Code: LSZ
• UDI-Device Identifier: 10190752158627
• UDI-Public: (01)10190752158627
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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: 770155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/16/2024
• 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