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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 Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
Event Type  malfunction  
Manufacturer Narrative
The actual date of event is unknown. 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. Device evaluated by bd.
 
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 Key12452086
MDR Text Key270762285
Report Number2016493-2021-60537
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 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2018
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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