MAUDE Adverse Event Report: MASIMO CORPORATION LNCS NEO ADH SENSOR

Model Number 2329

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/11/2014

Event Type  Other  

Event Description

The customer reported the following: "our picu is observing a recent increase in small blackish/ "burn" marks directly under the light source of the lncs-neo pulse oximeter probe.Have you heard any similar complaints from other hospitals? we are not sure if it is product or user related.The staff is supposed to re-position the sensors every 6 hrs, and we are not sure this is consistently being done.Any insight would be great".

Manufacturer Narrative

The sensor involved in this event was not returned, however retained samples were available for evaluation.The sensor was evaluated and passed all testing including a visual evaluation, continuity testing and skin temperature verification.The sensor tested was confirmed to function as designed.A product labeling review was conducted which included reviewing the directions for use (dfu).The user facility was contacted and appropriate instruction and clarification was provided to augment training they have already received.Info masimo receive indicated that the pt is doing fine outside of their underlying condition.The pt has been discharged from the picu.

• Brand Name: LNCS NEO ADH SENSOR
• 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
• Manufacturer Contact: jodi swindle ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 3947657
• MDR Text Key: 4538431
• Report Number: 2031172-2014-00109
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2329
• Device Catalogue Number: 2329
• Device Lot Number: K13MBN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Other