MAUDE Adverse Event Report: COVIDIEN LP NELLCOR; OXIMETER

Model Number MAXFAST

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Icu had an elderly, unresponsive patient with a pulse ox probe placed on his forehead.It's unclear how it happened, but when the probe was removed the nurse noted a small burn wound on the patient's forehead.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10762188
• MDR Text Key: 213890962
• Report Number: 10762188
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MAXFAST
• Device Catalogue Number: MAXFAST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29930 DA