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

Model Number 3100 A CIRCUIT

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire that the 3100 a circuit came apart while connected to a patient.The clinician quickly exchanged the circuit and the issue was resolved.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: 3100A CIRCUIT
• 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: 9235994
• MDR Text Key: 164100090
• Report Number: 2021710-2019-10944
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 09/25/2019

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: 3100 A CIRCUIT
• Device Catalogue Number: 771375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention