MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ADULT CO2 DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number AIRLIFE ADULT CO2 DETECTOR

Device Problem Device Sensing Problem (2917)

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

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

The sample device has been discarded and not available for analysis.Investigation is ongoing.Any additional information received from the customer will be included in a follow up report.

Event Description

The customer reported that the airlife adult co2 detector failed on three separate instances.During placement of the endotracheal tube, the device showed that the tube was place correctly but the tube was positioned incorrectly.The color should change to indicate that the tube is on the correct position, however it was not indicated on the device.At this time, there is no information regarding patient harm.

• Brand Name: AIRLIFE ADULT CO2 DETECTOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): SEEBREATH AB; birger jarlsgatan 2 stockholm; stockholms lan [se-01]; stockholm, ; SW
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9532532
• MDR Text Key: 173109477
• Report Number: 2050001-2019-00001
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE ADULT CO2 DETECTOR
• Device Catalogue Number: 2K8085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other