MAUDE Adverse Event Report: MASIMO CORPORATION LNCS DCI ADT; OXIMETER

Model Number 1863

Device Problem Invalid Sensing (2293)

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

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.

Event Description

It was reported that the sensor measures the wrong values.The sensor continued to provide values for 20 minutes even though the sensor was no longer on the finger.No known impact or consequence to patient.

• Brand Name: LNCS DCI ADT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618 1604
• 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 92618-1604 ; 9492977000
• MDR Report Key: 5496684
• MDR Text Key: 40215399
• Report Number: 2031172-2016-00324
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 1863
• Device Catalogue Number: 1863
• Device Lot Number: K15GWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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