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

Model Number 3100 A

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Vyaire field service representative (fsr) went onsite and evaluated the ventilator.Fsr noticed excessive amount of dust on the filter located at the bottom rear of the oscillator stand.No other failures found.Unit most likely overheated and shutdown.Fsr cleaned the filter, verified that the alarm board is ok and the thermistor was not damaged.Fsr checked all settings on the power width modulator.Verified that the ddi board is good.Checked all voltages coming from the power supply.Unit passed all calibrations and can be returned to service.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

It was reported to vyaire medical that the 3100a unit shuts off and would not power back on during patient use.The patient was transferred to another ventilator.The customer reported that there was no patient harm during this incident.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9945289
• MDR Text Key: 187212694
• Report Number: 2021710-2020-11672
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20090201
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1