MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7 HANDHELD; OXIMETER

Model Number 23785

Device Problem No Audible Alarm (1019)

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

Event Date 01/27/2016

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 the speaker was not working and a "mxcommfailure" error message was displayed.Although there were visual alarms present, there were no audible alarms.There is no report of any patient impact or consequence as a result of the issue.

Manufacturer Narrative

The radical-7 device involved in this event was returned for evaluation.The device display screen powers on and 'mx board failure' error message is observed.With this condition, the device was unable to operate for more than a few seconds.The mx board failure message is displayed continuously until the device was shut down by holding power key for a few seconds.The instrument board was found to be defective.The instrument board was replaced and the unit functioned as designed.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues prior to this event.

• Brand Name: RADICAL-7 HANDHELD
• 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: 5449371
• MDR Text Key: 38637074
• Report Number: 2031172-2016-00196
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 23785
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• 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