MAUDE Adverse Event Report: MASIMO CORPORATION RAD-5V HANDHELD; OXIMETER

Model Number 20763

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

It was reported that the end user observed the top led display is missing segments.There was no consequences or impact to the pt.

Manufacturer Narrative

The returned device was evaluated.During eval it was found that some of the led segments do no illuminate.Significant corrosion/contamination was found on the system board.The system board was replaced and the unit functioned as designed.

Manufacturer Narrative

Device expiration date: 06/11/2015.Brand name: rad-5v handheld.(b)(4).Model # 20763 , catalog # 1705.Pma 510(k) : k033998.Mfg date) : 12/18/2007.

• Brand Name: RAD-5V 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: 4913366
• MDR Text Key: 6025570
• Report Number: 2031172-2015-00921
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20763
• Device Catalogue Number: 1705
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2007
• 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