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U.S. Department of Health and Human Services

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

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ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 008870
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Event Description
It was reported that upon opening the box, 3 packages of sodasorb were busted open. No adverse patient effects were reported.
 
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Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
MDR Report Key12725629
MDR Text Key279258931
Report Number3012307300-2021-10484
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number008870
Device Catalogue Number008870
Device Lot NumberL02A-0065
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2021
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
Type of Device Usage Initial

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