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

Model Number 8300

Device Problems Failure to Read Input Signal (1581); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the device failed the leak down test during preventive maintenance.No additional information was provided.There was no patient involvement.

Manufacturer Narrative

A review of the device history record showed the device had a manufacture date of 29dec2009.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that the device failed the leak down test during preventive maintenance.No additional information was provided.There was no patient involvement.

• Brand Name: ALARIS ETCO2 MODULE
• 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: 11457704
• MDR Text Key: 242911919
• Report Number: 2016493-2021-29852
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• 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: 03/01/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1