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

Model Number 3100A

Device Problem Mechanical Problem (1384)

Patient Problem Pneumothorax (2012)

Event Date 10/13/2021

Event Type  Death  

Event 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.

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)
• Type of Device: 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
• MDR Text Key: 282320284
• Report Number: 2021710-2021-15039
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446002317
• UDI-Public: (01)10846446002317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 10273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death