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 No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by vyaire that the complaint sample 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 or any additional information becomes available a follow up emdr will be submitted.

Event Description

Customer reported serious condensation issues.The therapists reported that the circuit needed to be emptied every 2 hours or less.The condensate amount caused the tubing to fill up at the droop in the tubing.Issue was observed by clinician.There was not patient impact or harm.

Manufacturer Narrative

Since no sample was received from the customer a complete evaluation of the defective sample was not possible to perform.The dhr has identified that a defective crimping can potentially cause bad electrical connection of the heating wire to the power supply and therefore generate rain out in the circuit.Based on the investigation it is considered that the root cause of process/method error reported is related to the set up of the crimping equipment, the crimping height can be out of spec.Preventive actions include: qualify crimp quality monitors on crimper machines and re-train personnel on assembly according to manufacture 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; 26125 n riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n riverwoods blvd; mettewa, IL 60045
• MDR Report Key: 7182780
• MDR Text Key: 96992840
• Report Number: 8030673-2018-00404
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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: 0001097570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• 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