MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD SET NK - 12; OXIMETER

Model Number	4192
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
Event or Problem Description
The customer reported intermittent spo2 readings 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.No physical damage was observed.No short or open circuit was detected, and no intermittent short or open circuit was detected when the cable was manipulated.The returned cable and a lab sensor were placed on a simulator for 60 minutes and were able to obtain spo2 and pulse rate values throughout the entire 60 minutes of testing with no problem detected.
Event or Problem Description
The customer reported intermittent spo2 readings with the rd cable.No patient impact or consequences were reported.

• Brand Name: RD SET NK - 12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9634943
• Report Number: 3011353843-2020-00006
• Device Sequence Number: 2667605
• Product Code: DQA
• UDI-Device Identifier: 00843997010726
• UDI-Public: 00843997010726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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 Expiration Date: 01/21/2020
• Device Model Number: 4192
• Device Catalogue Number: 4192
• Device Lot Number: E18HZV
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1