MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS

Model Number 8300

Device Problem Failure to Cycle (1142)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the device was displaying error codes 500.5040 & 571.6240.No patient involvement.

Event Description

The customer reported the device was displaying error codes 500.5040 & 571.6240.No patient involvement.

Manufacturer Narrative

A review of the complaint history record was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 18jul2014.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.

• Brand Name: ALARIS ETCO2
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11061196
• MDR Text Key: 223609478
• Report Number: 2016493-2020-77705
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• Combination Product (y/n): N
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1