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

Model Number	4013
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the sensor appears to read inaccurately low saturation at times.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing 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 zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: is: (b)(6).H3 other text : no product returned.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the 3 returned sensors were evaluated.During evaluation, the sensors passed all visual and functional testing.During simulation testing, the sensors passed manual and preset conditions and provided accurate measurements.The sensors were determined to be functioning as designed.D.1 brand name was rd set newborn infant/pediatric, is rd set newborn neonatal d4.Catalog and model number was(b)(6).E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).E1.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 sensor appears to read inaccurately low saturation at times.No patient impact or consequences were reported.

• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 16828505
• Report Number: 3019388613-2023-00134
• Device Sequence Number: 7124709
• Product Code: DQA
• UDI-Device Identifier: 10843997009659
• UDI-Public: 10843997009659
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 05/01/2025
• Device Model Number: 4013
• Device Catalogue Number: 4013
• Device Lot Number: 22E38
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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
• Patient Sex: Unknown