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

Model Number 8300

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of the failure was not identified.A serial number was not provided therefore a review of the device history record cannot be performed.

Event Description

The customer reported error code 571.6200.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 12/27/2017.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.

Event Description

The customer reported error code 571.6200.No patient involvement.

• 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: 11101871
• MDR Text Key: 228727659
• Report Number: 2016493-2020-87144
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1