MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET YI; OXIMETER

Model Number	4054
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have not been returned to the investigation facility to allow for an analysis to be performed.If the products are received for evaluation or new information is obtained, a follow up report will be submitted.The initial reporter provided multiple event dates; however, could not determine which date of event belongs to which device.Therefore, the date of event was entered as (b)(6) 2021.
Event or Problem Description
The customer reported ten (10) sensors either had no light detected, intermittent light, or no trace detected when in use.No patient impact or consequences were reported.
Event or Problem Description
The customer reported ten (10) sensors either had no light detected, intermittent light, or no trace detected when in use.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensors were evaluated.Visual inspection found no physical damage.The sensors failed continuity testing because of an open in the cable.The sensors failed functional testing with a radical-7 and an error message was displayed.Two (2) of the 10 returned sensors were fully functional.

• Brand Name: RD SET YI
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12799901
• Report Number: 3019388613-2021-00311
• Device Sequence Number: 12159828
• Product Code: DQA
• UDI-Device Identifier: 00843997013079
• UDI-Public: 00843997013079
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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 Expiration Date: 09/01/2023
• Device Model Number: 4054
• Device Catalogue Number: 4054
• Device Lot Number: 20J1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown