MAUDE Adverse Event Report: VYAIRE MEDICAL 3100B; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Information (3190)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect ventilator device is available for analysis and an onsite service by a vyaire field service representative has been scheduled.Vyaire will include the field service report and or the device/component evaluation in a follow-up report once the final evaluation is completed.

Event Description

The customer reported that the amplitude setting fluctuated , during patient use on this ventilator device.The customer stated no known patient harm or injury was reported.

• Brand Name: 3100B
• 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: 9466934
• MDR Text Key: 170728225
• Report Number: 2021710-2019-11137
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003536
• UDI-Public: (01)10846446003536(11)20080206
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

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: 3100B
• Device Catalogue Number: 770880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2008
• 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): Other