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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION LNCS NEOPT
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MASIMO CORPORATION LNCS NEOPT Back to Search Results
Model Number LNCS NEOPT
Device Problems Incorrect Or Inadequate Test Results (2456); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2014
Event Type  malfunction  
Event Description
The following was reported by the user: after 3-5 days of usage, the spo2 signal/value seems incorrect.When the sensor is changed to a new one, the value is good.Moreover, after repositioning the sensor several times (every three hours over three days), the sensor adhesive tape is no longer sticky.The sensor is difficult to keep in place on the hand/foot of the baby during motion.
 
Manufacturer Narrative
The sensor involved in this event has not been received.As of the date of this report, the device is with customs.When the product is received and evaluated, a follow up report will be submitted.
 
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Brand Name
LNCS NEOPT
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.
calzada del oro no. 2001
parque industrial palaco
MX  
Manufacturer Contact
jodi swindle
40 parker
irvine, CA 92618
9492977000
MDR Report Key3793418
MDR Text Key4475144
Report Number2031172-2014-00036
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111888
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLNCS NEOPT
Device Catalogue Number2330
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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