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

Model Number 8300

Device Problem Failure to Cycle (1142)

Patient Problems No Patient Involvement (2645); 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

The customer reported error code 571.6240.No patient involvement.

Manufacturer Narrative

A review of the device history record for sn (b)(6) was performed from date of manufacture (b)(6) 2011 to the present date (b)(6) 2021 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.

Event Description

The customer reported error code 571.6240.No patient involvement.

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

The customer reported error code 571.6240.No patient involvement.

Event Description

The customer reported, error code 571.6240.No patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection, the service technician noted, that they reconnected ferrite cable into power supply connector for error code 571.6241.Replaced etco2 door for it get stuck, replaced broken right iui.A review of the device history record for sn#: (b)(6) was performed.From date of manufacture 11/30/2011 to the present date 1/20/2021 and confirmed, that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.Based on the findings, service determined, that the proximate cause of the reported issue was, due to loose ferrite cable into power supply connector.The customer reported problem was confirmed.The device was repaired.Passed all required testing and specifications, and released back to the customer.There are capa #'s noted, for the following parts replaced that have an already existing capa.Ca-2018-0161, for iui damages.

• 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: 11060870
• MDR Text Key: 223617405
• Report Number: 2016493-2020-77601
• 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,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/29/2020
• Supplement Dates FDA Received: 01/20/2021; 01/21/2021; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2722-2020
• Patient Sequence Number: 1