MAUDE Adverse Event Report: MASIMO CORPORATION RD SET OXIMETER ADHESIVE SENSOR- ADULT

Model Number 4475

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

4475- patient monitor was giving a desaturation reading of 54.Heart rate recorded by pulse oximeter correlated with ecg monitor leads, however, patient did not look cyanotic, was acting appropriately for age, not in distress, in fact was resting comfortably in caregiver's arms in a quiet alert state.Pulse oximeter probe was exchanged for a new pulse oximeter probe and desaturation on monitor resolved.4003 patient pulse oximeter stopped working.Red light no longer lit up, and no reading shown on monitor.Cord intact without wires showing.

• Brand Name: RD SET OXIMETER ADHESIVE SENSOR- ADULT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16814908
• MDR Text Key: 314018663
• Report Number: 16814908
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4475
• Device Catalogue Number: 4475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1