MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy Radical-7; Oximeter

Model Number	9500
Medical Device Problem Codes	Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2026
Type of Reportable Event	Death
Event or Problem Description
The customer reported, per the original information received on (b)(6) 2026: "we will be arranging the delivery of the below-mentioned devices for investigation, as they have been involved in an incident of suspected patient harm." on august 10, 2026 masimo received additional information that a "baby was born on the (b)(6) 2026 at 18:10 via spontaneous vaginal delivery.Born in good condition, subsequently collapse at 20 minutes of live and passed away at 20:10.Masimo radical7 bedside pulse co-oximeter never picked up the baby oxygen saturation and the heart rate before and after the collapse.The heart rate picked up by the machine was not consistent with what was auscultated with the stethoscope (heart rate picked up by machine well below 100 bpm, auscultated with stethoscope 135 bpm)." natural birth, mum arrived at 4pm and delivered at 6pm.Mum has quite severe anxiety, reports from nurses were that mum felt quite uncontrolled.
Additional Manufacturer Narrative
Other text: the returned device was evaluated.All alarm conditions were audible and visual, not distorted or raspy.The device was able to obtain measurements with all enabled parameters.A fluke biomedical index 2 simulator was utilized for spo2 and pulse rate testing, both the manual and preset simulation tests passed.There were no product performance issues identified relating to spo2 and pulse rate.The device was further tested for 1 hour using the neonatal setting and the fluke tester without any issues.Measurements were stable without loss throughout the duration of testing.Trend data was downloaded and reviewed, the reported date for the event was not recorded in the trend data.The customer continued to use the radical-7 after the date of event, which resulted in the overwriting of the trend data.The complaint regarding accuracy and obtaining measurements was not replicated during testing.E1.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

• Brand Name: Radical-7
• 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 ; +1(949)297-7167
• MDR Report Key: 50699810
• Report Number: 3019388613-2026-00611
• Device Sequence Number: 21246444
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: (01)00843997008358(11)250218
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 9500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• 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: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: RDS Dock Station SN.(b)(6),Sensor 4002.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Patient Weight: 160 LB
• Patient Race: White