• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION SD ALARIS ETCO2 MODULE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problems Crack (1135); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The affected devices have not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
It was reported that the device alarmed and displayed error codes / messages, 570. 6500 for oem serious module error and, 571. 6240 for oem missing sensor status. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11368890
MDR Text Key233189556
Report Number2016493-2021-27152
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 health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
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 Manufacturer02/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-