MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY O3 REGIONAL 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	11/15/2022
Type of Reportable Event	Malfunction
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.Additional patients information: patient #2: medwatch 20230533020000-2023-8002, patient age: 4 year(s), patient gender: female, patient weight: 16kg, ethnicity: hispanic/latino.Patient #3: medwatch 0533020000-2023-8003, patient age: 20 month(s), patient gender: male, patient weight: 9kg, ethnicity: hispanic/latino.Patient #4: medwatch 0533020000-2023-8004, patient age: 4 month(s), patient gender: male, ethnicity: hispanic/latino.Patient #5: medwatch 0533020000-2023-8005, patient age: 14 month(s), patient gender: male, patient weight: 12kg, ethnicity: hispanic/latino.Patient #6: medwatch 0533020000-2023-8006, patient age: 15 year(s), patient gender: male, patient weight: 55kg, ethnicity: hispanic/latino.Patient #7: 0533020000-2023-8007, patient age: 5 month(s), patient gender: male, ethnicity: hispanic/latino.Patient #8: medwatch 0533020000-2023-8008, patient age: 11 month(s), patient gender: female, ethnicity: hispanic/latino.Device not returned.
Event or Problem Description
The customer reported the "nirs probes placed on patients have resulted in different injuries, including skin tears, burns, and pressure injuries." there were no additional medical interventions reported.

• Brand Name: O3 REGIONAL 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: 16483278
• Report Number: 3019388613-2023-00054
• Device Sequence Number: 5262993
• 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): 02/07/2023

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: 02/07/2023
• Initial Report FDA Received Date: 03/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: O3 PEDIATRIC SENSOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Hispanic