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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 Calibration Problem (2890); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
It was reported that the device failed in co2 sensor calibration test and rotary door issue. 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 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.
 
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Brand NameALARIS SYSTEM
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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 Key15247183
MDR Text Key302603290
Report Number2016493-2022-178108
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403830013
UDI-Public(01)10885403830013
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
Report Date 08/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8300
Device Catalogue Number8300 ALARIS ETCO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2018
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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