MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CIRCUIT, INFANT DUAL LIMB,DHEAT, HI-FLOW; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Catalog Number AH165

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Cardiac Arrest (1762)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by vyaire that the actual device used on the patient is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.If a sample representative sample device or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported "caused code due to water.".

• Brand Name: CIRCUIT, INFANT DUAL LIMB,DHEAT, HI-FLOW
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 22745 savi ranch parkway; mettawa, IL 60045
• MDR Report Key: 6652310
• MDR Text Key: 77915983
• Report Number: 8030673-2017-00346
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AH165
• Device Lot Number: 0001049824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention