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

Model Number 3100A VENTILATOR

Device Problem Improper Flow or Infusion (2954)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  Death  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Contributing more to map then the bias flow/adjust knob, these settings are extremely out of the ordinary and to restart the unit they would have to increase the bias flow to restart because map has to be at least 20% of upper thumbwheel to start the unit and with these settings it is next to impossible to start the unit without manipulating the bias flow.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

The customer reported to vyaire medical that the 3100a ventilator unit depressurized and had a leak.The reporter confirmed that there is a patient involvement associated on this event.Patient was being transferred to another vent to allow the mother to hold the baby while the baby passed.The customer mentioned they don't think that the issue contributed to the patient's death.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• 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: 12325290
• MDR Text Key: 266680858
• Report Number: 2021710-2021-14345
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20090624
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A VENTILATOR
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2009
• 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