MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE; PUMP, INFUSION

Model Number 8300 ALARIS ETCO2 MODULE

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Manufacturer Narrative

The reported issue that the display board needed replacing could not be confirmed; no product was received for investigation.No device history or qn search was performed since no source device serial number was reported by the customer.The alaris etco2 module is used for monitoring.

Event Description

It was reported that the customer is replacing the display board.There was no patient involvement.

• Brand Name: 8300 ALARIS ETCO2 MODULE
• Type of Device: PUMP, INFUSION
• 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: 13307245
• MDR Text Key: 284118737
• Report Number: 2016493-2022-527437
• 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: Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/1900
• Device Model Number: 8300 ALARIS ETCO2 MODULE
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/1900
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/1900
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2825-2020
• Patient Sequence Number: 1