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	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an "intermittent connection of sats lead".There was no consequence or impact to the patient 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: initial reporter postal code exceeded the maximum allowable characters, postal code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.There was no damage or defects observed during the visual inspection.The device passed all functional testing and was able to obtain measurements with all the enabled parameters.During the internal inspection, the device had recessed pins in the tb20 cable connector.Initial reporter postal code exceeded the maximum allowable characters, postal code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported an "intermittent connection of sats lead".There was no consequence or impact to the patient 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 an "intermittent connection of sats lead".There was no consequence or impact to the patient 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: 18336385
• Report Number: 3019388613-2023-00279
• Device Sequence Number: 20934240
• Product Code: MWI
• UDI-Device Identifier: 00843997012775
• UDI-Public: (01)00843997012775(11)170906(21)3000007156
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 09/20/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/15/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2017
• 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