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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event, no patient impact h3 other text: device not returned.
Event or Problem Description
The rad-g "constantly displays incorrect values even after sensor replacement." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the customer returned the rad-g along with a concomitant patient cable.The device and cable were evaluated.The rad-g was able to obtain measurements when functionally tested with a lab tester and no product performance issues related to spo2 and pulse rate measurements were identified.The device was determined to be functioning as designed.However, an open in the cable at the torn bend relief area was found.A "sensor off patient" error message was triggered on the lab monitor when the cable was tested.
Event or Problem Description
The rad-g "constantly displays incorrect values even after sensor replacement." 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 ; 9492977862
• MDR Report Key: 23785721
• Report Number: 3019388613-2025-00168
• Device Sequence Number: 5712612
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: (01)00843997013284(11)210702
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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 20N94).
• Patient Sex: Unknown