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

Model Number	9847
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
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 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.Product not returned.
Event or Problem Description
The customer reported the rad-g "won't alarm when outside of parameters." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned rad-g was evaluated.The device was received in spot check mode.By design, the device does not have parameter limits in spot check mode and therefore, the device does not produce alarms.When the device was changed to continuous mode all alarm conditions were audible and visual.The device was determined to be functioning as designed.
Event or Problem Description
The customer reported the rad-g "won't alarm when outside of parameters." 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 21174914
• Report Number: 3019388613-2025-00001
• Device Sequence Number: 8537949
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: (01)00843997013284(11)240527
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: Other
• Device Model Number: 9847
• Device Catalogue Number: 9847
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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