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

Model Number 23785

Device Problems No Audible Alarm (1019); Failure to Charge (1085); Device Displays Incorrect Message (2591)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.During evaluation, the unit would not power on using battery power.The device was turned on with ac power and the error message "mx board failure" was displayed.The device was unable to obtain readings.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 two (2) years with no previously reported issues.

Event Description

It was reported that the unit had a "cracked touch screen, mxboardfailure, no sound, [and] doesn't charge." there is no report of any patient impact or consequence as a result of the issue.No further information is available.

• 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: 5478974
• MDR Text Key: 39640962
• Report Number: 2031172-2016-00275
• 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
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• 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: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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