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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM ADVANCE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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ORIDION MEDICAL MICROSTREAM ADVANCE ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number MVABO
Device Problem Device Damaged Prior to Use (2284)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  malfunction  
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Brand NameMICROSTREAM ADVANCE
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
IS 91235
Manufacturer (Section G)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
IS 91235
Manufacturer Contact
clay chandler
5920 longbow drive
boulder, CO 80301
3035306409
MDR Report Key14377974
Report Number8044004-2022-00007
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K181624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMVABO
Device Catalogue NumberMVABO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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