MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-57 PULSE CO-OXIMETER

Model Number	9216
Medical Device Problem Codes	No Display/Image (1183); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rad-57 "doesn't display correct numbers." there was no patient impact or consequence reported.It is unknown which parameter was being measured.
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.

• Brand Name: RAD-57 PULSE CO-OXIMETER
• 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: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; 9492977167
• MDR Report Key: 25038934
• Report Number: 3019388613-2026-00192
• Device Sequence Number: 10325008
• Product Code: DQA
• UDI-Device Identifier: 00843997006163
• UDI-Public: (01)00843997006163(11)240226
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 9216
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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