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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 Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the bite block caused injury to the gums of the upper jaw of the patient during the sedation process. The customer asked if there was a material change in manufacturing this product.
 
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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 Key14074638
MDR Text Key289019734
Report Number8044004-2022-00005
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,Followup
Report Date 04/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2022
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 Received03/23/2022
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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