MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; CARBON DIOXIDE GAS ANALYZE

Model Number 8300

Device Problems Device Alarm System (1012); Break (1069); Crack (1135); Degraded (1153); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

The actual date of event is unknown.Device was not returned to manufacturing facility for evaluation.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Device was not returned to manufacturing facility.

Event Description

It was reported that the device had channel error issue.There was no patient involvement.

Manufacturer Narrative

Additional information: imdrf annex a,b,c,d and g grid, manufacturer narrative(chr, dhr and shr).Omit: a1601 - device alarm system (1012), g0600101 - alarm, audible, c20 - no findings available.Device evaluated by bd service.A review of the complaint history for (b)(6) was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record showed the device had a manufacture date of 03jul2014.The review was performed from the date of manufacture to the present date 19jul2021.A review of the device history record for (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 service history record for (b)(6) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.

Event Description

It was reported that the device had channel error issue.There was no patient involvement.

• Brand Name: ALARIS SYSTEM
• Type of Device: CARBON DIOXIDE GAS ANALYZE
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 12126489
• MDR Text Key: 260247833
• Report Number: 2016493-2021-55328
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: (01)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
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8300
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1