MAUDE Adverse Event Report: MASIMO CORPORATION LNCS DCI ADT REUSABLE SNSR

Model Number 1863

Device Problems False Reading From Device Non-Compliance (1228); Image Display Error/Artifact (1304); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported by the biomedical engineer that they received sensors that do not work.Specifically, the sensor was unable to detect pr/spo2 values and the plethysmograph was a straight line with occasional "upward and downward" lines on plethysmograph view.When the crna applied a tc-1 to pt's ear, spo2/pr values and plethysmograph waveform were detected.It was noted that multiple attempts were made that day to use the dc-1 on subsequent operating room pts with the same results as noted above.During ongoing troubleshooting with the sensor attached to an lncs mp 10 cable and connected to a philips fast mx2, it was noted that the red/infrared lights were blinking and a "squiggly" line appeared in the plethysmograph view, but no values.Additionally, there were intermittent pr-spo2 values detected, but an irregular plethysmograph that did not correlate with the pulse rate.A new sensor was obtained from biomed and there have been no reported issues of a sensor not working.

Manufacturer Narrative

The device has been returned to masimo for eval.When the investigation is complete a follow up report will be submitted.

• Brand Name: LNCS DCI ADT REUSABLE SNSR
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A.; calzada del oro no. 2001; parque industrial palaco
• Manufacturer Contact: jodi swindle ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4207365
• MDR Text Key: 4968224
• Report Number: 2031172-2014-00133
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• 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
• Device Lot Number: K14A06
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PHILIPS MMS MX-2