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	03/24/2020
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 rad-5v device has missing segments.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the rad-5v device has missing segments.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: the device was shipped from a local facility to the main office for an evaluation to be completed.There is no evidence of the device having been received at the main office to allow for the evaluation to be completed.In the event the device is located a device evaluation will be completed and a follow up report will be submitted.H3 other text : device could not be located.
Additional Manufacturer Narrative
Additional manufacuring narrative: other text: the returned device was evaluated.Visual inspection found the shell was damaged.The device was able to power on and off using battery power and obtain measurements with all the enabled parameters.The display is stable and all the led segments light up upon start up.Internal inspection found contamination damages on u10 of the system circuit board.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the rad-5v device has missing segments.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: 9965377
• Report Number: 3011353843-2020-00059
• Device Sequence Number: 2728521
• Product Code: DQA
• UDI-Device Identifier: 00843997005524
• UDI-Public: 00843997005524
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K033998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

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: 04/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 07/22/2021
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 02/11/2021; 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1