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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION

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CAREFUSION SD 8300 ALARIS ETCO2 MODULE PUMP, INFUSION Back to Search Results
Model Number 8300 ALARIS ETCO2 MODULE
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time. There was no reported patient involvement.
 
Event Description
It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no reported patient involvement.
 
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Brand Name8300 ALARIS ETCO2 MODULE
Type of DevicePUMP, INFUSION
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 Key13632017
MDR Text Key293881607
Report Number2016493-2022-672401
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8300 ALARIS ETCO2 MODULE
Device Catalogue Number8300 ALARIS ETCO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2019
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2013
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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