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

Model Number 3100B

Device Problem Failure to Cycle (1142)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported evaluating the device and determined that the start/stop button was faulty on the ddi board (item 771415).A replacement ddi board 771415 was ordered.In the event that the device/component is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported an intermittent start/stop power cycle with this oscillator device.The customer stated no patient involvement with this event.

• Brand Name: 3100B 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: 8190942
• MDR Text Key: 131307733
• Report Number: 2021710-2018-09709
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• 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