MAUDE Adverse Event Report: COVIDIEN LP NELLCOR FOREHEAD SENSOR; OXIMETER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Injury (2348); Burn, Thermal (2530)

Event Date 12/02/2017

Event Type  malfunction  

Event Description

Patient observed to have a small deep tissue injury (dti) midline forehead, discovered under pulse oximeter forehead probe with band over probe.Site is also blistering.Device related to injury: covidien/nellcor forehead spo2 sensor.Injury located under infrared light.Determined injury to be a scab, not a dti.Appropriate category, this is a probe-related burn, non-pressure; however, necrotic tissue does not form overnight, there would have been skin impairment prior to this.No injury to patient from device.Device is not sequestered or available for return.

• Brand Name: NELLCOR FOREHEAD SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LP; 5870 stoneridge drive, suite 6; pleasanton CA 94588
• MDR Report Key: 7479106
• MDR Text Key: 107098467
• Report Number: 7479106
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• 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: 04/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR