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

Model Number 8300

Device Problem Device Sensing Problem (2917)

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 received an alarm - error code message.The error code displayed was 571.6241.There was no patient involvement.

Manufacturer Narrative

The investigation is still pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that the device received an alarm - error code message.The error code displayed was 571.6241.There was no patient involvement.

Event Description

It was reported that the device received an alarm - error code message.The error code displayed was 571.6241.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that an error code 571.6241 is confirmed due to a cable j3 to power board loosen up, reseated the cable j3.Also found damaged front case.Replaced it a new front case assembly.Performed leak down test and co2 calibration with passing results.The probable root cause of the reported issue was due to customer damage of the front case.A review of the device history record showed the device had a manufacture date of 09oct2014.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record 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 which did not confirm similar complaints with the same or related failure mode for this customer.

• 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: 11569050
• MDR Text Key: 242297915
• Report Number: 2016493-2021-500172
• 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,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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: 03/18/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1