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

Model Number	25198
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.Visual inspection revealed no external damage.During power-on test, the device was unable to turn on using the returned batteries.During power on testing, the c segment on the top 2nd right digit of the led display was unable to illuminate.The device was able to obtain readings and alarm when parameters were breached.Internal inspection isolated the led display failure to a faulty d2 component on the system board.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 some segments of the led's 7-segment display for the spo2 are blank.No patient impact or consequences were reported.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 7311693
• Report Number: 2031172-2018-00129
• Device Sequence Number: 11075169
• Product Code: DQA
• UDI-Device Identifier: 00843997005913
• UDI-Public: 00843997005913
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K033296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Service Personnel
• Remedial Action: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 25198
• Device Catalogue Number: 9214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1