MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET MP - 05; OXIMETER

Model Number	4082
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing 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 intermittent operation with the rd cable.No patient impact or consequences were reported.
Event or Problem Description
The customer reported intermittent operation with the rd cable.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.Visual inspection found no physical damage.The cable passed continuity tests, no short or open connection was detected, and no intermittent short or open connection was detected when the cable was manipulated.The cable passed functional tests and was able to obtain spo2 and pulse rate values.The returned cable and a lab sensor were placed on simulator for 15 minutes continuously and no problem was found.The cable was able to obtain spo2 and pulse rate values throughout the entire 15 minutes of testing.During evaluation the cable passed all visual and functional testing.The cable was found to be functioning as designed.

• Brand Name: RD SET MP - 05
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9742298
• Report Number: 3011353843-2020-00023
• Device Sequence Number: 2483393
• Product Code: DQA
• UDI-Device Identifier: 00843997009775
• UDI-Public: 00843997009775
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• 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,Followup
• Report Date (Section B): 01/30/2020

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: 4082
• Device Catalogue Number: 4082
• Device Lot Number: 19EFH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1