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

Model Number	3100 A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.
Event or Problem Description
The customer reported to vyaire medical that the 3100a ventilator shut down while on a patient and was moved to another ventilator.The customer confirmed that there is no patient harm on the reported event.
Additional Manufacturer Narrative
H10: a vyaire field service representative (fsr) went onsite and evaluated the ventilator.The broken limit valve was replaced, performed 2k pm (preventive maintenance) replaced ddi (dynamic displacement indicator) board and performed 7-year pm.The unit meets all factory specifications.

• 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: 9935926
• Report Number: 2021710-2020-11714
• Device Sequence Number: 643868
• Product Code: LSZ
• UDI-Device Identifier: 10846446005776
• UDI-Public: (01)10846446005776
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 22151-801
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention