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

Model Number 8300

Device Problem Calibration Problem (2890)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.

Event Description

It was reported calibration failure in twenty-three (23) etco2 modules during scheduled preventive maintenance.There was no patient involvement.

Event Description

It was reported calibration failure in twenty-three (23) etco2 modules during scheduled preventive maintenance.There was no patient involvement.

Manufacturer Narrative

Additional information: initial reporter phone #.

• Brand Name: ALARIS SYSTEM
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): 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: 18594120
• MDR Text Key: 333894494
• Report Number: 2016493-2024-11247
• Device Sequence Number: 1
• Product Code: CCK
• 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: Other,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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