MAUDE Adverse Event Report: MASIMO CORPORATION LNCS ADTX ADHESIVE SENSOR; OXIMETER

Model Number 1859

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

It was reported that there were 3 pts on the med surg floor received several small electrical shocks at the sensor site.The sensors had exposed wiring.The sensors were removed immediately.Cheri duncan (manager, cardiopulmonary) indicated that the nurses who were there are not available for any discussion at this time.The customer refused to provide the sensors and stated she needs to keep them per hospital policy.Cheri indicated that no medical intervention was required.She stated "we just changed the probe out to another one." she indicated that the pts' condition were stable when the issue occurred as well as their current condition.

Manufacturer Narrative

It was indicated by the customer that the sensor used during the reported event is not available for return as they will be keeping it per the hospital's policy.If new info is obtained, a follow up report will be submitted.

• Brand Name: LNCS ADTX ADHESIVE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.
• Manufacturer Contact: charlene johnson ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4812463
• MDR Text Key: 5925865
• Report Number: 2031172-2015-00815
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1859
• Device Catalogue Number: 1859
• Device Lot Number: K5BXA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1