MAUDE Adverse Event Report: MASIMO M-LNCS DB-I; OXIMETER

Model Number 2507

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

An attempt for product return and a request for additional information was made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.

Event Description

It was reported that there is a difference of 10 points when compared to a abg machine.There was no known impact or consequence to patient.

Manufacturer Narrative

The returned device was evaluated.During evaluation the device passed continuity testing, no short or open was detected and no intermittent short or open was detected when sensor is manipulated.Excessive corrosion at the detector copper shield caused sensor to be non-functional and a "sensor off" error message displayed.

• Brand Name: M-LNCS DB-I
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO; 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: 5256280
• MDR Text Key: 32484447
• Report Number: 2031172-2015-01363
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2507
• Device Catalogue Number: 2507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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