MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY 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	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported the rad-5 device has missing display segments.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the rad-5 device has missing display segments.No patient impact or consequences were reported.
Additional Manufacturer Narrative
The returned device was evaluated.Visual inspection upon receiving revealed some cracks in the chassis near the sensor port.The device was able to power on and off using battery power; however one segment on the top middle digit of the red led display did not illuminate.The customer's complaint was duplicated.Internal inspection of the device found a defective 7 segment display component d2 on the system board causing the led segments to not illuminate.However, the device was able to obtain readings and the alarm alert conditions were functional with audio and visual status indicators.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues prior to this reported event.

• Brand Name: RAD-5 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9269606
• Report Number: 3011353843-2019-00116
• Device Sequence Number: 13940909
• Product Code: DQA
• UDI-Device Identifier: 00843997005517
• UDI-Public: 00843997005517
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K033296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 25198
• Device Catalogue Number: 9196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1