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

Model Number	3100 B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the 3100b ventilator will not pressurize.At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: d10, g4, g7, h2, h3, h6 and h10.A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Performed 6 year & 3k pm on unit which took care of this issue.Product has been verified & tested ok.

• 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
• MDR Report Key: 10743861
• Report Number: 2021710-2020-12753
• Device Sequence Number: 16929126
• Product Code: LSZ
• UDI-Device Identifier: 10846446003468
• UDI-Public: (01)10846446003468(11)20090911
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 3100 B
• Device Catalogue Number: 770155-RFB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1