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

Model Number 8300

Device Problems Defective Alarm (1014); Break (1069); Circuit Failure (1089); Contamination (1120); Crack (1135); Failure to Calibrate (2440)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

The actual date of event is unknown.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.

Event Description

It was reported that the device had alarms for no apparent reason.There was no patient involvement.

Event Description

It was reported that the device had alarms for no apparent reason.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: c20 - no findings available,g0600101 - alarm, audible,a160106 - defective alarm (1014).Device evaluated by bd service.A review of the complaint history for sn (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 15may2012.The review was performed from the date of manufacture to the present date 15jul2021.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 service history record for sn (b)(6) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.

• Brand Name: ALARIS SYSTEM
• Type of Device: CARBON DIOXIDE GAS ANALYZER
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 12040044
• MDR Text Key: 257518014
• Report Number: 2016493-2021-54547
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1