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U.S. Department of Health and Human Services

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

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CAREFUSION SD ALARIS ETCO2 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problem Failure to Cycle (1142)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected device has not been received. A follow up report will be submitted with investigation results should the device be received for evaluation.
 
Event Description
It was reported that the device showed error "570. 6241- etco". There was no patient involvement.
 
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Brand NameALARIS ETCO2
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 Key11254430
MDR Text Key229476008
Report Number2016493-2021-21014
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
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 Manufacturer02/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2015
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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