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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION

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ORIDION MEDICAL ORIDION Back to Search Results
Model Number CS08657-01
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 02/21/2018
Event Type  malfunction  
Manufacturer Narrative
This product is not sold in us and is 510(k) exempt. This report is associated to a similar product sold in the us - 510(k) number k892432. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was a black smoke appears in the unit when it was plugged. The customer indicated that there was no patient involvement.
 
Manufacturer Narrative
Correction: (udi). Evaluation summary one sample was received for evaluation, a visual inspection was conducted and it was observed that the ferrite core pieces were found from damaged component l1 on the ac/dc pcba. Heat sink screw for u7 had small black marks and damage consistent with arcing. Ferrite core pieces were inspected and discoloration consistent with heat was found. Dc/dc pcba was removed. Potential root cause determined to be broken ferrite pieces causing arcing between the dc/dc pcba u7 heat sink screw and the chassis. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameORIDION
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 Key7331292
MDR Text Key102345388
Report Number8044004-2018-00003
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS08657-01
Device Catalogue NumberCS08657-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
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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