MAUDE Adverse Event Report: COVIDIEN LP NELLCOR MAXFAST; OXIMETER

Model Number MAXFAST

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

Patient Problem Burn, Thermal (2530)

Event Date 03/18/2019

Event Type  malfunction  

Event Description

Pulse oximeter device caused mild burn to patients forehead.

• Brand Name: NELLCOR MAXFAST
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8811235
• MDR Text Key: 151752496
• Report Number: 8811235
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• 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
• Device Lot Number: 205795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Date Report to Manufacturer: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA