MAUDE Adverse Event Report: MASIMO CORPORATION ROOT R7; OXIMETER

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/10/2015

Event Type  malfunction  

Event Description

It was reported that during a product demonstration in operating room, two rainbow sensors gave inaccurate sphb readings on two patients including the demonstrator.Sphb readings were about 3 g/dl lower than the readings obtained with a dci sc 200 sensor.The reading from dci sc 200 sensor were considered accurate as they correlated with an abg.The time difference between the sphb measurement and blood draw was <10 min.The reporter tested the sensors again the same day with different instruments, but the readings were always about 3-4 points different compared to the dci sc 200.No consequence or impact to patient.

Manufacturer Narrative

An attempt has 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.

Manufacturer Narrative

The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues prior to this reported event.

• Brand Name: ROOT R7
• 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.; calzada del oro no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: charlene johnson ; 52 discovery; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4617654
• MDR Text Key: 5591343
• Report Number: 2031172-2015-00466
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2015
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 82