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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8300
Device Problems Break (1069); Circuit Failure (1089); Crack (1135); No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Manufacturer Narrative
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
 
Event Description
It was reported that the device failed display test or light not working.There was no patient involvement.
 
Manufacturer Narrative
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.H3 other text : see manufacturer narrative.
 
Event Description
It was reported that the device failed display test or light not working.There was no patient involvement.
 
Manufacturer Narrative
**udi related data quality updates only** correction: unique device identifier (udi)# added pi to the unique device identifier (udi)# field.
 
Event Description
It was reported that the device failed display test or light not working.There was no patient involvement.
 
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Brand Name
ALARIS SYSTEM
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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 Key18381787
MDR Text Key331207221
Report Number2016493-2023-251297
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer12/13/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received12/04/2023
12/04/2023
Supplement Dates FDA Received01/19/2024
08/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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