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

Model Number 8300

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Patient Involvement (2645)

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 had failed co2 sensor accuracy during testing.No patient involvement.

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.A review of the device history record for sn (b)(6) was performed from date of manufacture 03/07/2011 to the present date 01/13/2021 and note that this device has been returned for service 1 time which correlates to the customer reported issue or service repairs.Also, there were no production failures indicated on the source device.

Event Description

It was reported that the device had failed co2 sensor accuracy during testing.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: 11103199
• MDR Text Key: 224861083
• Report Number: 2016493-2020-87261
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1