MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY LNCS TFA-1; OXIMETER

Model Number	3858
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other text: the response is being provided per the medwatch received by masimo.As the report was submitted as a voluntary report, with no customer details or other information available, masimo was unable to obtain any further information or obtain the product to conduct an investigation into the reported issue.If additonal details are obtained at a later date, a supplemental response will be provided.H3 other text : device not returned.
Event or Problem Description
Per medwatch report: staff noticed a trend in the masimo pulse ox not being accurate, possibly related to disposable sensor issues.There were no patient impact or consequences reported.

• Brand Name: LNCS TFA-1
• 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: 18456622
• Report Number: 3019388613-2024-00002
• Device Sequence Number: 19608170
• Product Code: DQA
• UDI-Device Identifier: 10843997008867
• UDI-Public: 10843997008867
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2023

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 Model Number: 3858
• Device Catalogue Number: 3858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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