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

Model Number 8300

Device Problems Break (1069); No Audible Prompt/Feedback (2282); Communication or Transmission Problem (2896)

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

Event Date 09/02/2021

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 failed to alarm.There was no patient involvement.

Manufacturer Narrative

Additional information: device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?, if other specify, imdrf annex a, b, c, d and g grids and manufacturer narrative (chr and dhr statements) omit: (b)(6)- no audible prompt / feedback (2282), g0600101 - alarm, audible, b17 - device not returned, c20 - no findings available, d15 - cause not established a review of the complaint history for this serialized unit did not confirm similar complaints, based on the same or related failure mode for this event.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Not applicable.Device evaluated by bd.

Event Description

It was reported that the device failed to alarm.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
• MDR Report Key: 12512193
• MDR Text Key: 272668265
• Report Number: 2016493-2021-61722
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1