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

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 this failure was not identified.

Event Description

It was reported that the device received an alarm - error code message.The error code displayed was 571.6241.The tech recommended checking and reseating the harness to oridion module, then replacing the etco2.There was no patient involvement.

Manufacturer Narrative

Technical support performed troubleshooting over the phone to determine the customer reported issue of npi 8300 error 571.6241.Technical support: check harness to oridion module and reseat harness.Replace etco2 board.Send in to factory for repair.Based on the troubleshooting results, technical support determined the proximate cause of the customer¿s reported issue.Had biomed reset the harness to the oridion module and error was cleared.Closing case.A review of the device history record showed the device had a manufacture date of 18oct2011.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) did not confirm similar complaints with the same or related failure mode for this customer.H3 other text : device not returned.

Event Description

It was reported that the device received an alarm error code message.The error code displayed was 571.6241.The tech recommended checking and reseating the harness to oridion module, then replacing the etco2.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: 11740315
• MDR Text Key: 248637514
• Report Number: 2016493-2021-503849
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1