MAUDE Adverse Event Report: COVIDIEN LP NELLCOR MAXFAST OXIMAX FOREHEAD SPO2 SENSOR, ADULT; OXIMETER

Model Number MAXFAST

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Pressure Sores (2326)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Patient had on a forehead spo2 sensor with headband for less than 24 hour timeframe.During patient assessment, nurse removed forehead sensor and observed deep tissue pressure injuries (dtpi) on right upper/middle forehead.The three small round spots approximately 0.4cm in diameter are consistent with the actual sensor and dtpi.The proximal area that is more linear is concerning for possible dtpi, however not as clear as to whether there was device or sensor over this area.The forehead spo2 sensor with headband was replaced with an ear clip sensor.This is the second of two recent events whereby nursing has reported deep tissue injuries related to the use of the forehead spo2 sensors with headband.It was recommended to nursing by education that they rotate the sensors frequently or to not use the headband as it adds extra pressure to the sensor.Nursing has provided feedback recommending that the manufacturer improve/enhance the instructions for use on the product, frequent rotation of the sensors (every two hours or more frequently) on the headband, and to rotate device on the sensor sticker.The forehead spo2 sensor with headband is generally used when unable to get an oxygen saturation level on the finger.Nurses are encouraged also to use an ear sensor as an alternative.Because we have had two similar events, we have pulled this product from the icus.

• Brand Name: NELLCOR MAXFAST OXIMAX FOREHEAD SPO2 SENSOR, ADULT
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11831189
• MDR Text Key: 250857597
• Report Number: 11831189
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 210810173H
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2021
• 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: 14600 DA
• Patient Weight: 65