MAUDE Adverse Event Report: MASIMO CORPORATION DISPOSABLE TRANSFLECTANCE SENSOR; OXIMETER

Device Problems Inadequate Instructions for Healthcare Professional (1319); Use of Device Problem (1670)

Patient Problems Pressure Sores (2326); Unspecified Tissue Injury (4559)

Event Date 04/21/2023

Event Type  Injury  

Event Description

Critically ill patient developed unstageable pressure injury to occiput, as well as multiple deep tissue injuries to the forehead associated with the use of masimo pulse oximetry devices and headband.The oximetry device contained 2 hard prongs that were placed directly on the forehead per manufacturer' recommendations.In addition, during vendor education to the icu units, there was no education or warnings that the product was to be used with "extreme caution with poorly perfused patients; skin erosion and pressure necrosis can be caused when the sensor is not frequently moved.Assess site as frequently as every (1) hour with poorly perfused patients and move the sensor if there are signs of tissue ischemia.During low perfusion, the sensor site needs to be assessed frequently for signs of tissue ischemia, which can lead to pressure necrosis." packaging does not carry warning regarding risk for pressure injuries.Previous equipment or supplies used for this purpose did not carry a risk for deep tissue or pressure injuries.The information regarding the risk was provided by the vendor after the pressure injury occurred and the hospital notified the vendor of the concern.Certified wound ostomy nurses assessed this patient's wounds and staged them according to guidelines for specialty.

• Brand Name: DISPOSABLE TRANSFLECTANCE SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 17337053
• MDR Text Key: 319370609
• Report Number: MW5119518
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other