MAUDE Adverse Event Report: MASIMO CORPORATION LNCS SC-I

Model Number 1863

Device Problems Invalid Sensing (2293); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported that the customer installed new led lights and c/o the lights affecting spo2 pleth.They notice this on their philips mp-50 with fast.Add'l info was received that stated: "the pleth had a weird distorted shape to it when the lights were on and the spo2 and pulse rate values were reasonable.When the lights were shut off, the spo2 values only changed a little 1-2% but the pulse rate values changed a bit more, up to 10 points difference.The rn's were not concerned about the values and this complaint did not affect their clinical decisions.They were just concerned about the changes to the pleth waveform." no pt incident was reported.

Manufacturer Narrative

Multiple attempts for product return were made.To date, the sensor has not yet been available to masimo to allow for an analysis to be performed.Add'l info including images were made available to masimo for review and the eval is currently underway.Upon completion of the investigation, a follow up report will be submitted.No pt incident was reported.

Manufacturer Narrative

Multiple attempts were made to obtain the product involved in the event, however the product has not been made available for further evaluation.Photos and information were provided by the customer to help characterize the problem and document any environmental factors in which these sensors were used.The spo2 technology in the monitor (philips mp50 with philips fast spo2 technology) is not a masimo product, therefore, masimo is unable to determine the exact cause of the monitor output/light interference issue.A review of the sensor's directions for use indicates that "high ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of the sensor." in addition, "to prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material, if required.Failure to take this precaution in high ambient light conditions may result in inaccurate measurements".

• Brand Name: LNCS SC-I
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.; calzada del oro no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: charlene johnson ; 52 discovery; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4001935
• MDR Text Key: 4954917
• Report Number: 2031172-2014-00102
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1863
• Device Catalogue Number: 1863
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1