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

Model Number	AIRLIFE ADULT CO2 DETECTOR
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not available for return, as it was discarded.No further evaluation can be completed at this time.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife adult co2 detector failed to change color in the presence of exhaled co2 during code blue on an intubated patient.It was also reported that the tube was in the correct position.The customer confirmed that there was no patient harm associated with the event.

• Brand Name: AIRLIFE ADULT CO2 DETECTOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9593562
• Report Number: 2050001-2020-00002
• Device Sequence Number: 2335433
• Product Code: CCK
• UDI-Device Identifier: 10885403185724
• UDI-Public: (01)10885403185724(10)CC19A10
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE ADULT CO2 DETECTOR
• Device Catalogue Number: 2K8085
• Device Lot Number: CC19-A10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1