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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER LNCS Y-I; OXIMETER
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MASIMO - 40 PARKER LNCS Y-I; OXIMETER Back to Search Results
Model Number 2258
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/16/2017
Type of Reportable Event Malfunction
Additional Manufacturer 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 that the device will only give readings in the 80's, compared to other sensors that are reading "more normal" (in the 90's).No consequences or impact to patient was reported.
 
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Brand Name
LNCS Y-I
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key6632867
Report Number2031172-2017-00645
Device Sequence Number18971749
Product Code DQA
UDI-Device Identifier00843997000062
UDI-Public(01)00843997000062(17)200201(10)K17BCG
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K041815
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
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 Number2258
Device Catalogue Number2258
Device Lot NumberK17BCG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2017
Initial Report FDA Received Date06/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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