MAUDE Adverse Event Report: COVIDIEN/MALLINCKRODT NELLCOR MAXFAST FOREHEAD SPO2 SENSOR; NELLCOR FOREHEAD SPO2

Model Number 3583 MAXFAST

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 08/10/2016

Event Type  Injury  

Event Description

The pt suffered an apparent pressure ulcer on his forehead related to the use of the nellcor spo2 forehead sensor.This is a trend that our system has identified.No significant injury to the pt.

• Brand Name: NELLCOR MAXFAST FOREHEAD SPO2 SENSOR
• Type of Device: NELLCOR FOREHEAD SPO2
• Manufacturer (Section D): COVIDIEN/MALLINCKRODT; 1915 olive street; st. louis MO 63103
• MDR Report Key: 6144358
• MDR Text Key: 61526820
• Report Number: MW5066486
• Device Sequence Number: 1
• Product Code: DQA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3583 MAXFAST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 70 YR
• Patient Weight: 116