MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY SET LNCS INF PULSE OX ADH SENSOR; OXIMETER

Model Number	2328
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that "within the past two months, i have noticed that the wires become exposed on our pulse ox cords when attempting to change out the brown sticker.The sticker remains adhered to the white plastic piece that typically covers the wires, requiring the entire cord to be replaced.I discussed this with many nurses on my unit, who all agreed that this is not an isolated incident.I believe that this has affected both the neonatal and infant cords".There was no patient impact or consequence reported.

• Brand Name: SET LNCS INF PULSE OX ADH 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24734702
• Report Number: 3019388613-2026-00116
• Device Sequence Number: 9242506
• Product Code: DQA
• UDI-Device Identifier: 10843997000915
• UDI-Public: (01)10843997000915
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 2328
• Device Catalogue Number: 2328
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 22 MO
• Patient Sex: Male