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U.S. Department of Health and Human Services

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

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ORIDION MEDICAL LTD ORIDION MEDICAL; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number CS08651
Device Problem No Audible Alarm (1019)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
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 that nurse call function was enabled, it does not transmit alarm back to nurse station.The patient involvement is unknown.Medtronic is requesting for additional information.
 
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Brand Name
ORIDION MEDICAL
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ORIDION MEDICAL LTD
po box 45025
jerusalem 91450
Manufacturer (Section G)
ORIDION MEDICAL LTD
po box 45025
jerusalem 91450
Manufacturer Contact
sharon murphy
15 hampshire street
mansfield, MA 02048
2034925267
MDR Report Key6959051
MDR Text Key90644348
Report Number8044004-2017-05008
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 consumer,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
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? No
Date Manufacturer Received09/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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