MAUDE Adverse Event Report: VYAIRE MEDICAL HME TYPE I ADULT 50/CS; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Catalog Number 003003-A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Hypoxia (1918)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

At this time, vyaire has not received the suspect device/component for evaluation.If additional information is received a supplemental report will be submitted.

Event Description

The customer reported that a small plastic piece was observed to be stuck in the filter.The event happened during patient use.All of a sudden the patient had stopped breathing and the ventilator kept alarming, so the staff immediately switched to the ambu-bag and stabilized the patient.No further patient impact was indicated.Upon retracing their steps, the staff discovered a plastic piece in the filter.

Manufacturer Narrative

Results of investigation: the failure analysis lab received the suspected sample and performed a failure investigation.The reported issue was confirmed in the laboratory setting.A root cause of the reported issue was determined to be the manufacturing process.

• Brand Name: HME TYPE I ADULT 50/CS
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7795394
• MDR Text Key: 117566687
• Report Number: 3005515211-2018-00001
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

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 Catalogue Number: 003003-A
• Device Lot Number: SJ111705
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention