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

Model Number	9797
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the spo2 keeps losing signal for the rad-97 device.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted., other, other text: e1.Initial reporter postal code exceeded allowable field length, initial reporter postal code is as follows: (b)(6).E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).H3 other text : device not returned.
Additional Manufacturer Narrative
The returned device was evaluated.During the investigation, recessed pins were observed on the tb20 cable connector.The recessed pins resulted in the unit being unable to recognize the cable to obtain measurements.E1.Initial reporter postal code exceeded allowable field length, initial reporter postal code is as follows: (b)(6).Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the spo2 keeps losing signal for the rad-97 device.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 (9797).
Event or Problem Description
The customer reported the spo2 keeps losing signal for the rad-97 device.There was no patient impact or consequence reported.

• Brand Name: RAD-97 PULSE CO-OXIMETER
• 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: 18271250
• Report Number: 3019388613-2023-00274
• Device Sequence Number: 14454613
• Product Code: MWI
• UDI-Device Identifier: 00843997012775
• UDI-Public: (01)00843997012775(11)200706(21)3000058562
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2023

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: 9797
• Device Catalogue Number: 9797
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 09/20/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/08/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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