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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORIDION MEDICAL ORIDION MEDICAL
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ORIDION MEDICAL ORIDION MEDICAL Back to Search Results
Model Number CS08651
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2017
Event Type  malfunction  
Manufacturer Narrative
One sample was received for analysis and the reported issue was confirmed.The defective speaker was replaced 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.
 
Event Description
Medtronic received a report the unit did not generate an audible alarm.Customer indicated there was no patient involvement with this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report the unit did not generate an audible alarm.Customer indicated there was no patient involvement with this event.
 
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Brand Name
ORIDION MEDICAL
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
MDR Report Key6593155
MDR Text Key76183999
Report Number8044004-2017-05003
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K024300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCS08651
Device Catalogue NumberCS08651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2017
Date Manufacturer Received04/28/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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