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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS INF-3; OXIMETER
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MASIMO - 40 PARKER LNCS INF-3; OXIMETER Back to Search Results
Model Number 2319
Medical Device Problem Codes Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/31/2017
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 the following issue: "if the probe goes bad (we have had a few), there is no alarm, the patient is then hooked up with no sats on the monitor." no consequences or impact to patient were reported.
 
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Brand Name
LNCS INF-3
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6778949
Report Number2031172-2017-00778
Device Sequence Number19193615
Product Code DQA
UDI-Device Identifier10843997000885
UDI-Public(01)10843997000885(17)191201(10)K16NWY
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K101896
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
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 Model Number2319
Device Catalogue Number2319
Device Lot NumberK16NWY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/19/2017
Initial Report FDA Received Date08/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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