MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEONATAL/ADULT PULSE OXIMETER

Model Number	4003
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the sensors were tested and shown to have difficulty sensing o2 saturation and pulse.There were no patient impact or consequences reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  the sensor was determined to be functioning as designed., other, other text: the customer returned 5 sensors to masimo.The lot numbers are 23fmz, 23cbz, 21gyl, 20deg, and 23gcs.
Additional Manufacturer Narrative
Masimo's initial report identified the model as number 4003.Model number 4003 is associated with the gudid number.This supplemental mdr confirms the model number as 4003 to ensure correlation with the gudid number.Masimo also reviewed the udi number as reported in gudid.The correct entry is (b)(4).Any additional entries associated with this part number will be revised in gudid.
Event or Problem Description
The customer reported the sensors were tested and shown to have difficulty sensing o2 saturation and pulse.There was no patient impact or consequences reported.
Additional Manufacturer Narrative
This correction updates the udi number to include the di and pi fields, all numbers, letters, parentheses, and symbols.This correction is for lot number 23fmz.
Event or Problem Description
The customer reported the sensors were tested and shown to have difficulty sensing o2 saturation and pulse.There was no patient impact or consequences reported.
Additional Manufacturer Narrative
Other text: udi related data quality updates only.This correction updates the udi number to include the di and pi fields, all numbers, letters, parentheses, and symbols.This correction is for lot number 23cbz.
Event or Problem Description
The customer reported the sensors were tested and shown to have difficulty sensing o2 saturation and pulse.There was no patient impact or consequences reported.

• Brand Name: RD SET NEONATAL/ADULT 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: 17962362
• Report Number: 3019388613-2023-00260
• Device Sequence Number: 7530529
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: (01)10843997009598(17)260301(10)23CBZ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2023

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 Expiration Date: 03/01/2026
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Device Lot Number: 23CBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 06/11/2024; 07/10/2024; 07/10/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 06/24/2024; 07/23/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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: RD SET NEO CABLE (PN 4003, LOT 23CBZ).
• Patient Sex: Unknown