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

Model Number 8300

Device Problems Break (1069); Crack (1135); Degraded (1153); Communication or Transmission Problem (2896); Mechanics Altered (2984); No Apparent Adverse Event (3189)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

The actual date of event is unknown.Device evaluated by bd service.A review of the complaint history for sn (b)(4) 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 02mar2012.The review was performed from the date of manufacture to the present date 28jun2021.A review of the device history record for sn (b)(4) 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)(4) was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.Device was not returned to manufacturing facility.

Event Description

It was reported that the device had failed preventive maintenance.There was no patient involvement.

• 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
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 12083614
• MDR Text Key: 258899991
• Report Number: 2016493-2021-54990
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: (01)10885403830013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2021

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: Other
• Device Model Number: 8300
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1