MAUDE Adverse Event Report: MASIMO CORPORATION MASIMOSET LNCS TC-I SPO2 REUSABLE EAR SENSOR; OXIMETER, EAR

Model Number 1895

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Narrative from staff: the patient was found with an unstageable pressure injury to the right naris related to an oxygen sensor clip.

• Brand Name: MASIMOSET LNCS TC-I SPO2 REUSABLE EAR SENSOR
• Type of Device: OXIMETER, EAR
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 11990730
• MDR Text Key: 255946033
• Report Number: 11990730
• Device Sequence Number: 1
• Product Code: DPZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1895
• Device Catalogue Number: 1895
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16060 DA
• Patient Weight: 98