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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS DC-I; OXIMETER
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MASIMO - 40 PARKER M-LNCS DC-I; OXIMETER Back to Search Results
Model Number 2501
Medical Device Problem Code Sensing Intermittently (1558)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/1901
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., initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Device not returned.
 
Event or Problem Description
The customer reported the sensor's led turned off with no readings or error messages.No patient impact or consequences were reported.
 
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Brand Name
M-LNCS DC-I
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8364489
Report Number2031172-2019-00095
Device Sequence Number1832822
Product Code DQA
UDI-Device Identifier00843997003193
UDI-Public00843997003193
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K051212
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date (Section B) 02/05/2019
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 Number2501
Device Catalogue Number2501
Device Lot Number18HDU
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2019
Initial Report FDA Received Date02/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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