MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7 COLOR SCREEN HANDHELD

Model Number 9500

Device Problems Erratic or Intermittent Display (1182); Improper Device Output (2953)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

Customer states that they are experiencing "phantom touches".The term is what they use to describe - when no touch input to the device however, the screen is reacting as if it was being touched.No pt incident was reported.

Manufacturer Narrative

The device has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.No pt incident was reported.

Manufacturer Narrative

The returned device was evaluated.During an internal inspection of the device, the unit was found to have intermittent contact of three (3) pins due to a cold solder.A service history record review reveals that this unit was in the field for over one (1) year with no reported issues prior to this reported event.

• Brand Name: RADICAL-7 COLOR SCREEN HANDHELD
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A.; calzada del oro no. 2001; parque industrial palaco; mexicali, baja california CA 21600 ; MX 21600
• Manufacturer Contact: charlene johnson ; 52 discovery; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4047986
• MDR Text Key: 4907669
• Report Number: 2031172-2014-00129
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9500
• Device Catalogue Number: 9500
• Other Device ID Number: 23785
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2014
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1