MAUDE Adverse Event Report: MASIMO RADICAL-7; OXIMETER

Model Number 25054

Device Problems No Display/Image (1183); Loss of Power (1475); Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

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

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

It was reported that the device was on patient.Went in patient room and device screen blank.All lights were lit up.Rebooted machine, device scattered through many screens without anyone touching screen.Wiped screen off and attempted to use again.Device worked, but then again stopped working.We believe this is a mx board failure.There was no known impact or consequence to patient.

Manufacturer Narrative

The returned device was evaluated.During this testing, the unit was able to power on but started alarming and displayed "mx board failure" message.The mx-5 board was replaced and the "mx-board" message went away.The unit was determined to be functioning as designed.A service history record review reveals that this unit was in the field for four (4) weeks with no previous reported issues prior to this reported event.

• Brand Name: RADICAL-7
• 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: 5175228
• MDR Text Key: 29802773
• Report Number: 2031172-2015-01203
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25054
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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
• Patient Age: 50 YR