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U.S. Department of Health and Human Services

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

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NULL ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 1410AG
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
It was reported that with 2% sevoflurane input, the board measures only by 1. 3%. With 2% isoflurane input, it measures by 2%. Agent xcal in sevoflurane on the factory service menu shows unusual value such as 114. Iso xcal offset shows unusual value at 10831. No adverse patient effects were reported.
 
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Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section G)
NULL
MDR Report Key12808305
MDR Text Key280768516
Report Number3012307300-2021-11204
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1410AG
Device Catalogue Number1410AG
Device Lot Number4095443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2021
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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