MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY 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	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection showed no damage.When powered on the display had various segments missing in both the siq and pi bar as well as the spo2 and bpm displays.Internal inspection showed corrosion on the u2 component of the instrument board.The corrosion on the board caused the d1, d2, d5 and d6 to not properly illuminate.The customer complaint was duplicated.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the device is having a display issue and not working properly.No patient impact or consequences were reported.

• Brand Name: RAD-5V PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9182658
• Report Number: 3011353843-2019-00089
• Device Sequence Number: 2591648
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/18/2019

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: 09/09/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1