MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY LNCS-II RAINBOW; OXIMETER

Model Number	4067
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of 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.Health effect impact code 4650: no adverse event; no patient impact.H3 other text: product not returned.
Event or Problem Description
The customer reported the sensor has "stopped taking measurements." no patient impact or consequences were reported.
Additional Manufacturer Narrative
Other text: the returned sensor was evaluated; however, the concomitant patient cable was not returned.A short between the resistor and inner shield of the sensor was observed during continuity testing.A "replace sensor" error message was triggered on the lab monitor when the sensor was functionally tested.Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the sensor has "stopped taking measurements." no patient impact or consequences were reported.

• Brand Name: LNCS-II RAINBOW
• 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: 21904855
• Report Number: 3019388613-2025-00025
• Device Sequence Number: 17146098
• Product Code: DQA
• UDI-Device Identifier: 00843997015608
• UDI-Public: (01)00843997015608(11)240813(10)24HAB
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K071024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 4067
• Device Lot Number: 24HAB
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RA25-05 CABLE (LOT 22ACQ)
• Patient Sex: Unknown