MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE® GAS INJECTION NEBULIZER (GIN); NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number AIRLIFE® GAS INJECTION NEBULIZER (GIN)

Device Problem Defective Component (2292)

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

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported that the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the airlife gas injection nebulizer is not humidifying the circuit during patient use.The device catheter is too long and bendable causing the catheter tip to be placed above the water when the bottle is half empty.The patient had an episode of desaturation and bradycardia.Emergency reintubation was needed.At this time no information was provided on remedial action taken.

Manufacturer Narrative

Device evaluation: d4, g4, h2, h3, h4, h6 and h10.Result of investigation: the vyaire failure analysis laboratory performed analysis on the picture received.It was visible that tube is too long, so if it is not placed properly at the bottom of the bottle, it can provoke the failure mode reported by the customer.However, the ifu instructions for use clearly indicates that the end of the tube through which the solution entered must be placed at the bottom of the bottle.Sample is necessary to confirm that the product does not produce moisture as reported by the customer.Therefore the defect reported by the customer was not confirmed and root cause cannot be determined.

Manufacturer Narrative

Device evaluation: d10, g4, g7, h2, h6 and h10.Result of investigation: vyaire medical received one opened and decontaminated sample of p/n 441g airlife gas injection nebulizer (gin).Sample was evaluated per pqas 441g performing visual inspection and functional test, obtaining as a result that the sample is acceptable, so the defect reported by the customer was not confirmed.In question about the length of the tube p/n 037-90059 misty ox, xxl inlet tube misty ox according to dwg 037-90059 it was observed that its length is ideal for the product.However the ifu instructions for use clearly indicates that the end of the tube through which the solution entered, must be placed at the bottom of the bottle, the ifu also has the "single use" symbol and it was reported that the device was used in two patients.The root cause cannot be determined.

• Brand Name: AIRLIFE® GAS INJECTION NEBULIZER (GIN)
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9522080
• MDR Text Key: 188822539
• Report Number: 8030673-2019-00062
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE® GAS INJECTION NEBULIZER (GIN)
• Device Catalogue Number: 441G
• Device Lot Number: 001086304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other