MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP SENSOR; OXIMETER

Model Number	4050
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Skin Discoloration (2074)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch #mw5159272, the customer reported "on skin check, noted a discolored area under the nail just below where the probe was sitting on the nail".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the device has been returned to the investigation facility to allow for an analysis to be performed.When the product is evaluated or new information is obtained, a follow up report will be submitted.
Additional Manufacturer Narrative
Other text: the returned sensor was evaluated.The sensor passed all visual and functional testing.The sensor was determined to be functioning as designed.
Event or Problem Description
Per medwatch#: mw5159272, the customer reported "on skin check, noted a discolored area under the nail just below where the probe was sitting on the nail".There was no patient impact or consequence reported.

• Brand Name: RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP SENSOR
• 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: 20557699
• Report Number: 3019388613-2024-00128
• Device Sequence Number: 16956700
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)230310(10)23CFW
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/01/2024

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 Model Number: 4050
• Device Lot Number: 23CFW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White