MAUDE Adverse Event Report: MASIMO CORPORATION (949) 297-7055 LNCS RESUSABLE PULSE OXIMETRY SENSOR; OXIMETER

Device Problem Inaccurate Information (4051)

Patient Problems Ventilator Dependent (2395); Low Oxygen Saturation (2477)

Event Date 03/25/2014

Event Type  Injury  

Event Description

This letter is to inform you of an event that occurred at (b)(6) medical center in (b)(6) on (b)(6) 2014 in which it was alleged a masimo lncs reusable pulse oximetry sensor provided inaccurate oxygen saturation values.As a result of this issue, the patient was intubated and placed on a ventilator.At the time of the event, the masimo sensor was connected to a ge healthcare carescape b850 patient monitor.According to the customer, the spo2 was reading 98-100%, however the arterial blood gas showed 80%.The hospital biomedical technician and masimo representative were able to reproduce the issue when the sensor was incorrectly applied upside down.The ge healthcare carescape b850 monitor was tested and found to be working in accordance with manufacturer's specifications.The masimo lncs reusable pulse oximetry sensor is manufactured by the masimo corporation which is headquartered in irvine, ca.The masimo corporation was informed of this event on (b)(6) 2014.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LNCS RESUSABLE PULSE OXIMETRY SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION (949) 297-7055
• MDR Report Key: 17516388
• MDR Text Key: 321052272
• Report Number: MW5123337
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1