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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 Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes Cyanosis (1798); Low Oxygen Saturation (2477)
Date of Event 09/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.
 
Event or Problem Description
The customer reported: "there was an infant in the nicu and by the time the reprocessed sensor pulse oximeter neonatal adhesive picked up that the infant's saturation level was low and notified the rn, the infant was blue.".
 
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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 Key6933529
Report Number2031172-2017-00939
Device Sequence Number655956
Product Code DQA
UDI-Device Identifier10843997000922
UDI-Public10843997000922
Combination Product (Y/N)N
Initial Reporter StateNC
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 Nurse
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? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/01/2020
Device Model Number2329
Device Catalogue Number2329
Device Lot NumberK17C2J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2017
Initial Report FDA Received Date10/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
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