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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 CS08651-02
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The technician verified customer complaint of a burning smell. Unit was picked up and a small rattling noise was heard. Burning smell was observed with the unit fully assembled. No attempts were made to power on the device. Unit was disassembled and when the rear housing was removed, a small piece of ferrite was found loose inside the unit. Ferrite was broken off of the ac/dc l1 inductor. Further disassembly found that the burning smell was due to a piece of the broken ferrite becoming wedged between the dc/dc pcba and the chassis, causing a short. Burn marks were found on the chassis and the dc/dc pcba. Both ac/dc and dc/dc pcbas were removed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the device had a burning electrical smell and battery icon was in red. The customer indicated there was no patient involvement.
 
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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
15 hampshire street
mansfield, MA 02048
3035306582
MDR Report Key7441036
MDR Text Key106258957
Report Number8044004-2018-00007
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112368
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS08651-02
Device Catalogue NumberCS08651-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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