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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM

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ORIDION MEDICAL MICROSTREAM Back to Search Results
Model Number CS08657-02
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2017
Event Type  malfunction  
Manufacturer Narrative
The information provided indicates that the sample is expected to be returned for analysis. If the sample is returned, a summary of the analysis will be provided in a supplemental report. 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.
 
Event Description
Medtronic received a report from a biomedical engineer where it was initially reported that the unit was dropped and had a damaged front case on the display. The customer called back on the same day and provided information that alleged that the unit started smoking when connected to ac power and a foul odor came from the device. No complication to the end user was reported.
 
Manufacturer Narrative
The customer complaint of faint tones was confirmed. The defective main pcb was replaced. Repair including function testing to test protocol was performed and the unit passed all testing. The unit was reset to standard/ factory settings. 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
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem
Manufacturer (Section G)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6386450
MDR Text Key69645676
Report Number8044004-2017-05000
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS08657-02
Device Catalogue NumberCS08657-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
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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