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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS

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CAREFUSION SD ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problem Device Alarm System (1012)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A review of the complaint history record in trackwise and sap was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer. A review of the device history record showed the device had a manufacture date of 10/09/2018. The review was performed from the date of manufacture to the date of product release for distribution. A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was involved in a production failure which does not correlate to the customer reported issue.
 
Event Description
It was reported that there was an unknown alarm-error code/message and the device was "not working. " there was no patient involvement.
 
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Brand NameALARIS ETCO2 MODULE
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
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
shari lynn groth
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11373655
MDR Text Key233333754
Report Number2016493-2021-28117
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 other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
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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