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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS NEO-3; OXIMETER
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MASIMO - 40 PARKER LNCS NEO-3; OXIMETER Back to Search Results
Model Number 2320-9
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/25/2018
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 saturation only reaches 90-95%.The inaccuracy was detected by the home user first when monitoring their own child.No patient impact or consequences were reported.
 
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Brand Name
LNCS NEO-3
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7493291
Report Number2031172-2018-00270
Device Sequence Number10822751
Product Code DQA
UDI-Device Identifier10843997000892
UDI-Public10843997000892
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K101896
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial
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 Date09/01/2020
Device Model Number2320-9
Device Catalogue Number2320
Device Lot Number17JBY
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2018
Initial Report FDA Received Date05/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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