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

Catalog Number 003003

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire has reached out to customer three times to request the complaint sample for further investigation.A ups label was also provided to the customer.Unfortunately, vyaire has not received the complaint sample for evaluation.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

A customer contacted vyaire to report that the hme 0003003 was breaking apart while on patients.The patient was receiving ventilation therapy when the issue occurred.The issue was discovered when staff had noticed loss in vent pressure and the ventilation had alarmed.They had to replace the unit with a new 003003.The circuit was set-up with the hme between the circuit and the patient.No patient harm was indicated.

Manufacturer Narrative

Code 81 other: vyaire had reached out to customer three times to request device for further investigation.Unfortunately, vyaire never received the complaint device for evaluation.However, photo of the sample was returned and analyzed along with the retained samples.It was determined that the manufacturing equipment contributed to the reported failure.A device history record (dhr) of the lot number revealed no issues.Corrective actions were indicated.

• Brand Name: HME TYPE I ADULT
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8570920
• MDR Text Key: 143941635
• Report Number: 3005515211-2019-00004
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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 Catalogue Number: 003003
• Device Lot Number: SJ0718022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention