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U.S. Department of Health and Human Services

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

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CAREFUSION SD ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problems Material Fragmentation (1261); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer reported problem was confirmed. The device was repaired, passed all required testing and specifications, and released back to the customer. Based on the findings, service determined that the proximate cause of the reported issue was due to a loose j3 cable causing error code 571. 6240. A review of the device history record for (b)(4) was performed from (b)(6) 2016 to (b)(6) 2020 and confirmed that this device was not previously returned for servicing. Also, there were no production failures indicated on the source device.
 
Event Description
It was reported that the device displayed alarm error codes/messages as a calibration error. There was no patient involvement.
 
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Brand NameALARIS 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
bijal patel
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10564390
MDR Text Key208115027
Report Number2016493-2020-09821
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,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2020
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 Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2016
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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