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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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NULL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 1410AG
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Date 09/28/2021
Event Type  malfunction  
Event Description
It was reported that incorrect tube being used on the 1410ag board. The tube between the 3way valve and the disk filter has incorrect specifications. No adverse patient effects were reported.
 
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Brand NameBCI
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section G)
NULL
MDR Report Key12716066
MDR Text Key279041013
Report Number3012307300-2021-10432
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1410AG
Device Catalogue Number1410AG
Device Lot Number4103600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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