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

Model Number 23786

Device Problems No Audible Alarm (1019); Display or Visual Feedback Problem (1184)

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

Event Date 06/21/2016

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

Customer reported that the radical-7 had "no display although the button illuminates and no other sound/alerts when the sp02 cable/sensor is plugged in, hence we were thinking that this fault could be more than just a display failure." 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 no display was observed and the device was unable to detect sensors or take measurements due to defective components on the core and mx boards.The core board and mx boards were replaced and the device functioned as designed.

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 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: 5800691
• MDR Text Key: 49749608
• Report Number: 2031172-2016-00826
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23786
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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