MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEWBORN NEONATAL; OXIMETER

Model Number	4013
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on the medwatch report "pulse oximeter flatlined on monitor.Noticed on central monitor but did not alarm.Went into room and baby was resting comfortably.Saturation monitor was still on foot and properly positioned." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned sensor passed continuity and functional testing.Spo2 and pulse rate values were able to be obtained on the lab monitor.During additional testing, the sensor obtained continous readings throughout the testing period.The sensor functioned as designed.

• Brand Name: RD SET NEWBORN NEONATAL
• 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: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19222664
• Report Number: 3019388613-2024-00048
• Device Sequence Number: 15188955
• Product Code: DQA
• UDI-Device Identifier: 10843997009659
• UDI-Public: 10843997009659
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: 12/01/2025
• Device Model Number: 4013
• Device Catalogue Number: 4013
• Device Lot Number: 22NTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: LOT 23CMM; PART NUMBER 4078; RD RAINBOW SET R25-12, PATIENT CABLE
• Patient Sex: Unknown