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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO; OXIMETER
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MASIMO - 40 PARKER LNCS NEO; OXIMETER Back to Search Results
Model Number 2329
Medical Device Problem Code High Readings (2459)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/07/2019
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 device was providing high spo2 readings when compared to the values received from blood gas tests.No patient impact or consequences were reported.
 
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Brand Name
LNCS NEO
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8383727
Report Number2031172-2019-00100
Device Sequence Number18937592
Product Code DQA
UDI-Device Identifier10843997000922
UDI-Public10843997000922
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K101896
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 02/07/2019
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 Expiration Date09/01/2021
Device Model Number2329
Device Catalogue Number2329
Device Lot Number18JUC
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 02/07/2019
Initial Report FDA Received Date03/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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