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

Model Number 8300

Device Problem Computer Operating System Problem (2898)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

It was reported that the device had an 8300 error 500.5040.There was no patient involvement.

Manufacturer Narrative

Technical support performed troubleshooting with the customer over the phone and confirmed npi 8300 error 500.5040.Technical support: 1.Connect 8015 to system maintenance.2.Start the appropriate flash task for the module.3.When prompted "next" on asm, click on next and within 3 seconds attach module.If it took to long to connect module, user will get a timeout error and will have to restart the process.4.When connected, they may change the serial number if needed.Click "update" just to change serial number or click "flash" to update software on module.5.When flashing is complete click on "finish" step through process flashing software on etco2 module to 9.33 software was successfully upgraded.A review of the device history record for (b)(6) was performed from date of manufacture 03/08/2010 to the present date 01/25/2021 and note that this device has been returned for service once without correlation to the customer reported issue.Also, there were no production failures indicated on the source device.Based on the troubleshooting results, technical support determined the proximate cause of the customer¿s reported issue.Technical support: 1.Connect 8015 to system maintenance.2.Start the appropriate flash task for the module.3.When prompted "next" on asm, click on next and within 3 seconds attach module.If it took to long to connect module, user will get a timeout error and will have to restart the process.4.When connected, they may change the serial number if needed.Click "update" just to change serial number or click "flash" to update software on module.5.When flashing is complete click on "finish" step through process flashing software on etco2 module to 9.33 software was successfully upgraded.The customer reported problem was confirmed.There were no existing capa¿s listed for any of the parts listed in this file for repair.

Event Description

It was reported that the device had an 8300 error 500.5040.There was 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: 11069693
• MDR Text Key: 224349371
• Report Number: 2016493-2020-80054
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1