MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL 7; OXIMETER

Model Number 25054

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.During evaluation the unit was able to power on, however, the radical-7 display shuts down within a few seconds (screen blank) and 10 beeps watchdog alarm is triggered.With this condition, the device was unable to operate for more than a few seconds.The 10 beeps alarm looped continuously until the device was shut down by holding power key for a few seconds.Instrument board u21 pin 1 to 6 was found to be out of specifications.This failure caused by instrument board u21 (current limiter ic) failure.The instrument broad u21 was replaced and the unit functioned as designed.

Event Description

It was reported that unit does not stay on.Per the customer, "when you power up the unit, it will come on like normal.Display a full battery, but within the time it take the wifi on and access the settings the unit power down on its own.Tried multiple times, and swapped the batteries".There was no error message or audible alarm observed.No known impact or consequence to patient.

• Brand Name: RADICAL 7
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 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: 6485657
• MDR Text Key: 72548612
• Report Number: 2031172-2017-00461
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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