MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number	3100B VENT,115V,60HZ,DOM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - 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.H3 other text : device not returned yet.
Event or Problem Description
It was reported that the 3100b ventilator piston position was not displaying.The amplitude, inspiratory time (normally 33), and frequency (normally 3-15) were all displaying abnormal values of 52.As of this time, there is no information about patient involvement associated with this reported event.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• 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: 17666697
• Report Number: 2021710-2023-18054
• Device Sequence Number: 6324683
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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: 3100B VENT,115V,60HZ,DOM
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/31/2023
• 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