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

Model Number	3100A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/13/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported to vyaire medical that the o2 (oxygen) blender was not working properly.Ino (inhaled nitric oxide) was administered via ino delivery device with high flow oxygen blender.The blender read 100% however the analyzer read 21%.They attempted to increase oxygenation, the infant sustained a pneumothorax and health declined rapidly and the patient passed with parents.They discovered that the nut retaining the knob of the o2 blender was loose and was not providing friction fit required for adjustment of o2 concentration.The customer confirmed that the health care provider attempted to increase oxygenation.However, the infant's health sustained pneumothorax.Infant's health declining rapidly and passed with parents.
Additional Manufacturer Narrative
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 was received.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13006341
• Report Number: 2021710-2021-15039
• Device Sequence Number: 14812817
• Product Code: LSZ
• UDI-Device Identifier: 10846446002317
• UDI-Public: (01)10846446002317
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 10273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown