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

Model Number 3100 B

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Vyaire medical was able to verify the reported issue during testing and evaluation.During testing, it was discovered that the reported issue was due to electrical arcing of the power supply.As a resolution, the power supply was replaced.

Event Description

It was reported that during training, the unit sparked and there was a burning smell was noted.The unit powers up, but the panel meter's reads are incorrect.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8691101
• MDR Text Key: 147737391
• Report Number: 2021710-2019-10364
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543(11)20121218
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2012
• 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