MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RADICAL DOCKING STATION, RDS-3; OXIMETER

Model Number	25254
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported a spark came out of the back of the rds-3 device and it stopped working.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection upon receiving revealed no external damage or defects.The device was able to power on using ac power.A good known radical-7 was able to be charged while in the docking station and was able to establish communication with the docking station; however, the ac inlet module was damaged.The docking station failed both production and verify hipot tests due to the damaged ac inlet module.After temporarily replacing the ac inlet with one from a known good rds, the customer¿s docking station was able to pass hipot testing.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues prior to this reported event.
Event or Problem Description
The customer reported a spark came out of the back of the rds-3 device and it stopped working.No patient impact or consequences were reported.

• Brand Name: RADICAL DOCKING STATION, RDS-3
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10017909
• Report Number: 3011353843-2020-00064
• Device Sequence Number: 2089252
• Product Code: DQA
• UDI-Device Identifier: 00843997001595
• UDI-Public: 00843997001595
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110028
• 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): 04/07/2020

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: Other
• Device Model Number: 25254
• Device Catalogue Number: 9023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1