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

Model Number 8300

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

The affected devices have not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported that the device displayed an error message for oem missing sensor status; alarm went off.No additional information was provided.There was no patient involvement.

Event Description

It was reported that the device displayed an error message for oem missing sensor status; alarm went off.No additional information was provided.There was 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

It was reported that the device displayed an error message for oem missing sensor status; alarm went off.No additional information was provided.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 error code 571.6240 was confirmed due to a cable j3 to power board loosened up.Reseated the cable j3.Also found damaged front case and rear case.Replaced them with new front and rear case assembly.Performed leak down test and co2 calibration with passing results.A review of the device history record for (b)(6) was performed, which showed the device had a manufacture date of 07mar2012 and confirmed that this device was not involved in a production failure which correlates to the customer reported issue.The review was performed from the date of manufacture to the date of product release for distribution.A review of the complaint history record was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

• Brand Name: ALARIS ETCO2 MODULE
• 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: 11282928
• MDR Text Key: 230692525
• Report Number: 2016493-2021-23078
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

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: 02/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 03/15/2021
• Supplement Dates FDA Received: 03/03/2021; 04/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1