MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5V PULSE OXIMETER

Model Number	26819
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer 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 device doesn't display measurements correctly.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found the outer shell is cracked.When powered on not all led segments illuminate when obtaining measurements.Internal inspection found contamination damage on the system circuit board that prevents some of the led segments from lighting up.A service history record review reveals that this unit was in the field for over seven (7) months with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the device doesn't display measurements correctly.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: 11276443
• Report Number: 3011353843-2021-00017
• Device Sequence Number: 4228758
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033998
• 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): 01/13/2021

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: 26819
• Device Catalogue Number: 9197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1