MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-8 HORIZONTAL SIGNAL EXTRACTION PULSE OXIMETER

Model Number	9190
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer 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.
Event or Problem Description
The customer reported that the rad-8 device turns off by itself.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Masimo's initial report identified the model as number 26816.Model number 9190 is associated with the gudid number.Part number 26816 is the subassembly to part number 9190.This supplemental mdr updates the model number to 9190 and brand name to rad-8 horizontal signal extraction pulse oximeter to ensure correlation with the gudid database.
Event or Problem Description
The customer reported the rad-8 device turns off by itself.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
This correction updates the udi number to include the di and pi fields, all numbers, letters, parentheses, and symbols.Product not returned.
Event or Problem Description
The customer reported the rad-8 turns off by itself.There was no patient impact or consequence reported.

• Brand Name: RAD-8 HORIZONTAL SIGNAL EXTRACTION PULSE OXIMETER
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 18420848
• Report Number: 3019388613-2023-00285
• Device Sequence Number: 15497161
• Product Code: DQA
• UDI-Device Identifier: 00843997005647
• UDI-Public: (01)00843997005647(11)211025(21)M213520
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2023

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: 9190
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: No
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 06/11/2024; 07/10/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 06/21/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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