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

Model Number	3100 A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).The reported issue was also by rt dept while doing the patient circuit calibration.As a resolution, the customer will replaced the panel meter.The suspect/device component has not been returned to vyaire.Therefore, a definitive root cause cannot be determined.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
It is reported to vyaire medical that 3100a ventilator experienced a fluctuating map between 53-58 cm on the display while checking the zero/span on this unit.The external meter is reading stable at 37 cm.The customer confirmed that there was no patient involvement associated with the 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
• MDR Report Key: 10451808
• Report Number: 2021710-2020-12332
• Device Sequence Number: 14523892
• Product Code: LSZ
• UDI-Device Identifier: 10846446003024
• UDI-Public: (01)10846446003024(11)20100203
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1