MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy Rad-97; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Model Number	9738
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the device shuts down without any warning.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.The device was found to power on and off utilizing ac and battery power.The battery was found to be swollen and have a low full-charge capacity of 3501mah.This low battery-capacity caused the device to discharge at a quicker rate than designed, with the device providing a low battery alarm once the battery charge declined.The customer's reported issue of the device powering off without warning was not replicated in testing, however the short device battery life was replicated in testing.Health effect impact code: no adverse event; no patient impact.

• Brand Name: Rad-97
• Common Device Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
• 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 ; +1(949)297-7167
• MDR Report Key: 50170050
• Report Number: 3019388613-2026-00494
• Device Sequence Number: 18613605
• Product Code: MWI
• UDI-Device Identifier: 00843997012317
• UDI-Public: (01)00843997012317(11)220809
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 9738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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
• Patient Sex: Unknown