MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY O3 INFANT AND NEONATAL SENSOR; OXIMETER, TISSUE SATURATION

Model Number	4384
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported "near-infrared spectroscopy (nirs) probe on the right flank resulted in a stage 1 pressure ulcer/injury." no additional medical intervention was reported.
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.

• Brand Name: O3 INFANT AND NEONATAL SENSOR
• Common Device Name: OXIMETER, TISSUE SATURATION
• 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16526983
• Report Number: 3019388613-2023-00064
• Device Sequence Number: 5259127
• Product Code: MUD
• UDI-Device Identifier: 10843997013496
• UDI-Public: 10843997013496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182429
• 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): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: 4384
• Device Catalogue Number: 4384
• Device Lot Number: 22DNY
• 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: 03/01/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 5 KG
• Patient Ethnicity: Hispanic