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 Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 05/20/2017

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 that the "exhalation valve obstructed because water is collecting there, causing a malfunctioning of the vent." the patients experienced bradycardia and desaturation that required ppv (positive pressure ventilation) with the resuscitation bag.The infant recovered.".

Manufacturer Narrative

Unfortunately the representative samples were not available for further evaluation so the failure and root cause could not be confirmed.It has been identified that a defective crimping in the heater wire can potentially cause a bad electrical connection of heating wire to the power supply and therefore generate rain out in the circuit.Due to this potential failure a capa has been initiated with the following containment actions have been performed.Vyaire is doing inspection for 200% for wire resistance to ensure circuits are functional.Inspection for correct wire retainer position is also being performed.The following preventive actions are being implemented vyaire is qualifying crimp quality monitors on the crimper machines, and personnel are being retrained on the assembly procedure.

• 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 ; 26125 n. riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 6652316
• MDR Text Key: 77914374
• Report Number: 8030673-2017-00347
• 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,Followup
• Report Date: 02/20/2018

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: 01/31/2018
• 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): Required Intervention