MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5V PULSE OXIMETER

Model Number	25199
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.Visual inspection upon receiving revealed no external damage.The device turned on using lab stock batteries.The device was able to obtain spo2 and pulse rate readings.The unit was found to visually and audibly alarm during alarm conditions.Customer complaint was duplicated, leds segments intermittently do not light up and led segments are flickering.Performed diode testing and diode segments failed at 1.8vdc.Observed contamination on led segments on system board.Contamination caused display flickering and prevented leds from lighting up.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the rad-5v display flickers and part of the led display does not illuminate.No patient impact or consequences were reported.

• Brand Name: RAD-5V PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8158380
• Report Number: 2031172-2018-00570
• Device Sequence Number: 1913126
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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
• Operator of Device: Health Professional
• Device Model Number: 25199
• Device Catalogue Number: 9197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1