MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RED DCI SENSOR; OXIMETER

Model Number	2054
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring 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 sensors suddenly stopped working.No patient impact or consequences were reported.
Event or Problem Description
The customer reported sensors suddenly stopped working.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the two returned sensors had no damage or defects observed during the visual inspection.An open connection in the cable was observed on the detector circuit.The sensors issued a ¿sensor off patient" error message during functional testing.

• Brand Name: RED DCI SENSOR
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17620168
• Report Number: 3019388613-2023-00206
• Device Sequence Number: 6118975
• Product Code: DQA
• UDI-Device Identifier: 00843997001243
• UDI-Public: 00843997001243
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 2054
• Device Catalogue Number: 2054
• Device Lot Number: 22GJD
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RED DCI SENSOR LOT 22F9V.
• Patient Sex: Unknown