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U.S. Department of Health and Human Services

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

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CAREFUSION SD ALARIS SYSTEM CARBON DIOXIDE GAS ANALYZER Back to Search Results
Model Number 8300
Device Problems Crack (1135); Degraded (1153); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
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 31 mar 2021. The review was performed from the date of manufacture to the present date (b)(6) 2021. 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 in preventive maintenance. There was no patient involvement.
 
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Brand NameALARIS SYSTEM
Type of DeviceCARBON 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 Key12158482
MDR Text Key261228173
Report Number2016493-2021-55579
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031741
Number of Events Reported1
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 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8300
Device Catalogue Number8300 ALARIS ETCO2 MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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