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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORIDION MEDICAL NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
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ORIDION MEDICAL NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number N85
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device handheld monitor was received for evaluation.The battery had a date code of (b)(6) 2016, which is past the two-year limit where it would normally be replaced at factory service.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, the unit was not really used on a patient.There was a code blue on a patient, they were going to use this unit on the patient to check spo2 and co2.But when the unit was turned on, it was red and did not give any kind of readings at all.
 
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Brand Name
NELLCOR
Common Device Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ORIDION MEDICAL
7 hamarpeh st.
jerusalem 91235
MDR Report Key8095641
Report Number8044004-2018-00012
Device Sequence Number1988114
Product Code CCK
UDI-Device Identifier10884521172043
UDI-Public10884521172043
Combination Product (Y/N)N
Initial Reporter CountryVT
PMA/510(K) Number
K915494
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN85
Device Catalogue NumberN85
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2018
Initial Report FDA Received Date11/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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