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U.S. Department of Health and Human Services

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

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ORIDION MEDICAL MICROSTREAM ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number PM35MN02
Device Problem Material Integrity Problem (2978)
Patient Problem Cyanosis (1798)
Event Date 03/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during use, the patient was desaturated to 54% for 3 minutes and the device did not alarm. It was also stated that the device was previously shown a white screen and power cycled by itself causing to be disconnected from vital sync not to be alarmed also. The patient looked blue or cyanotic when found out.
 
Manufacturer Narrative
Additional info: date received by mfr, device evaluated by mfr, evaluation codes. Evaluation summary: one sample was received for evaluation. No fault was found in the monitor operation. The alarms were set to disable and thus did not provide the notification during the event. The monitor has shown to be operating correctly under the alarm settings that have been set through the institutional defaults. The monitor is recording the trends and providing information on saturation and pulse rate as expected. The investigation found the device to function normally. Information has been added to the database and trends will continue to be monitored. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMICROSTREAM
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
Manufacturer (Section G)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key8456510
MDR Text Key140012921
Report Number8044004-2019-00007
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPM35MN02
Device Catalogue NumberPM35MN02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2019 Patient Sequence Number: 1
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