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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS DCI; OXIMETER
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MASIMO - 40 PARKER M-LNCS DCI; 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 01/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.During inspection, the sensor passed visual analysis.Eeprom content verification did not identify any issues.The sensor failed continuity testing due to an exposed solder joint on the green conductor, causing a short between the green conductor and inner shield of the sensor cable.When the sensor was connected to a masimo monitoring device, the device was able to generate a "sensor off patient" error message.
 
Event or Problem Description
The customer reported: "intermittently losing signal.".No patient impact or consequences were reported.
 
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Brand Name
M-LNCS DCI
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7405545
Report Number2031172-2018-00206
Device Sequence Number13796184
Product Code DQA
UDI-Device Identifier00843997003193
UDI-Public00843997003193
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K051212
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Emergency Medical Technician
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
Device Catalogue Number2501
Device Lot Number17JMK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2018
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2018
Initial Report FDA Received Date04/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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