MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEOPT CS-3; OXIMETER

Model Number 4479

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

The customer reported the sensor provided low spo2 readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the device has not been returned to the investigation facility to allow for an analysis to be performed.  if the product is received for evaluation or new information is obtained, a follow up report will be submitted.

• Brand Name: RD SET NEOPT CS-3
• Type of Device: 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16456671
• MDR Text Key: 310440795
• Report Number: 3019388613-2023-00050
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997013311
• UDI-Public: 10843997013311
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K101896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 4479
• Device Catalogue Number: 4479
• Device Lot Number: 22K7G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1