MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	9799
Medical Device Problem Codes	Sensing Intermittently (1558); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.H3 other text : product not returned.
Event or Problem Description
The customer reported the rad-97 powered off by itself even when the device battery was fully charged and has an intermittent problem with reading spo2.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device had a depleted battery and would turn off after a few minutes on battery power, however, a low battery alarm was triggered when the device shut down.A "replace sensor" error message was displayed and measurements could not be obtained as a result of recessed pins at the patient cable connector.
Event or Problem Description
The customer reported the rad-97 powered off by itself even when the device battery was fully charged and has an intermittent problem with reading spo2.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: udi related data quality updates only.This correction updates the udi information, 510k number, and model number to ensure alignment with gudid.The 510k number in gudid was updated to k212161 to correspond with masimo's 4-digit model number (9799).
Event or Problem Description
The customer reported the rad-97 powered off by itself even when the device battery was fully charged and has an intermittent problem with reading spo2.There was no patient impact or consequence reported.

• Brand Name: RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 18314293
• Report Number: 3019388613-2023-00278
• Device Sequence Number: 15132957
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: (01)00843997012782(11)200915(21)3000061895
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 11/17/2023

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
• Device Catalogue Number: 9799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 09/20/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/18/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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