MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G; OXIMETER

Model Number	9847
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the returned rad-g and concomitant patient cable were evaluated.The rad-g was able to obtain measurements for all enabled parameters and all alarm conditions were audible and visual.No product performance issues related to spo2 or pulse rate were identified during testing.The device was determined to be functioning as designed.The cable passed visual inspection, however, an open in the cable inside the bend relief area of the rad-g connector was found.A "sensor off patient" error message was triggered on the host monitoring device when the cable was functionally tested with a lab sensor and monitor.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the rad-g was providing "inaccurate readings." there was no patient impact or consequence reported.

• Brand Name: RAD-G
• 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 25063819
• Report Number: 3019388613-2026-00198
• Device Sequence Number: 18667115
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: (01)00843997013284(11)210622
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K212876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 9847
• Device Catalogue Number: 9847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: G15-05 CABLE (LOT 24MAL)
• Patient Sex: Unknown