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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 2501-7
Medical Device Problem Code Sensing Intermittently (1558)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/03/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During evaluation the sensor passed all functional testing.The unit failed visual inspection due to residue observed at the m15 connector.The sensor was determined to be functioning as designed.(b)(6).
 
Event or Problem Description
The customer reported intermittently would display values and then suddenly display no values with no error message.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 Key6826274
Report Number2031172-2017-00841
Device Sequence Number1430624
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
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 Number2501-7
Device Catalogue Number2501
Device Lot NumberK16JEE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2017
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2017
Initial Report FDA Received Date08/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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