MAUDE Adverse Event Report: MASIMO CORPORATION 4D DC SENSOR MEDIUM

Model Number SC-X

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/21/2014

Event Type  malfunction  

Event Description

The customer requested an evaluation of her pronto-7 and sensors.She indicated that the device and sensor are not picking up readings and/or not giving accurate readings.According to the customer, she tested the product on herself by placing the medium sensor on opposite ring fingers which on the left hand 15 and right hand 13.She indicated that the results showed inaccurate or no readings on each sensor.Customer would like device and sensors checked for accuracy.No blood gas test samples are available.No patient incident reported.

Manufacturer Narrative

Eight (8) attempts have been made in order to obtain the product for evaluation.On (b)(6) 2014, the user facility indicated that the device will be returned to masimo for further evaluation.Once the investigation on the unit is performed, a follow up report will be submitted.

• Brand Name: 4D DC SENSOR MEDIUM
• 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: 3925170
• MDR Text Key: 4580835
• Report Number: 2031172-2014-00092
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC-X
• Device Catalogue Number: 9401
• Other Device ID Number: 23612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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 Age: 30 YR
• Patient Weight: 59