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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOMOLINE ISA CO2; OXIMETER
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NOMOLINE ISA CO2; OXIMETER Back to Search Results
Model Number 27015
Medical Device Problem Code Low Readings (2460)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/20/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
 
Event or Problem Description
The customer reported the module reads way too low.No patient impact or consequences were reported.
 
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Brand Name
NOMOLINE ISA CO2
Common Device Name
OXIMETER
MDR Report Key12455353
Report Number3011353843-2021-00235
Device Sequence Number3924647
Product Code CCK
UDI-Device Identifier00843997014328
UDI-Public00843997014328
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K063167
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 08/20/2021
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 Number27015
Device Catalogue Number9921
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2021
Initial Report FDA Received Date09/10/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured05/24/2019
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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