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

Model Number	9799
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	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device is displaying inaccurate hr readings.There was no patient impact or consequence reported.
Event or Problem Description
The customer reported that the device is displaying inaccurate hr readings.There was no patient impact or consequence reported.
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.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.The device was found to have a broken and recessed cable connector frame on the instrument housing.This damage was not found to correlate with the customer's reported issue nor impact the device's performance related to accuracy during the investigation.The device was able to obtain measurements for all enabled parameters throughout the duration of testing, and all alarm conditions were audible and visual.No product performance issues related to spo2 or pr were identified in both the manual and simulator testing.The customer's reported issue was not replicated, root cause cannot be identified.H6.Component code - connector frame: 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: 50422971
• Report Number: 3019388613-2026-00560
• Device Sequence Number: 10405396
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: (01)00843997012782(11)230215
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K212161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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: 9799
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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