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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
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CAREFUSION SD ALARIS ETCO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problems Device Sensing Problem (2917); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, further information was not provided.
 
Event Description
It was reported that the same etco2 error occurred in modules which are not included in the initial scope of the 8300 recall from august.The facility has identified at least 21 etco2 modules with the same issue (error codes 570.6200 and 570.6500), but with serial number/manufacturing dates that fall beyond the recall scope according to their bd contact.There was no report of patient incident or harm.Although requested, further information was not provided.
 
Manufacturer Narrative
The reported issue that the etco2 module had channel error, could not be confirmed; no product or device logs were returned for investigation.The device was not returned for investigation or repair.No failure data exists to review.Therefore, the proximate cause of the customer¿s reported issue cannot be determined.The reported event of device had etco2 channel error, was created to document the event that the customer reported.The customer did not return the device for evaluation.No device history search was performed since no source device serial number was reported by the customer.A review of the april 2021 complaint review board (crb) did not find an increasing trend for the reported issue of ¿etco2 channel error" based on the crb review and the limited information provided no further investigation actions will be performed.
 
Event Description
It was reported that the same etco2 error occurred in modules which are not included in the initial scope of the 8300 recall from august.The facility has identified at least 21 etco2 modules with the same issue (error codes 570.6200 and 570.6500), but with serial number/manufacturing dates that fall beyond the recall scope according to their bd contact.There was no report of patient incident or harm.Although requested, further information was not provided.
 
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Brand Name
ALARIS ETCO2
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11350864
MDR Text Key233109530
Report Number2016493-2021-26759
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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