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U.S. Department of Health and Human Services

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

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CAREFUSION SD ALARAIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problem Failure to Read Input Signal (1581)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported that the device failed preventive maintenance. No patient involvement.
 
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Brand NameALARAIS 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
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11266979
MDR Text Key230121400
Report Number2016493-2021-22523
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 health professional,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2021
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 Manufacturer12/18/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-2721-2020

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