MAUDE Adverse Event Report: COVIDIEN LP INVOS; OXIMETER, TISSUE SATURATION

Model Number 5100C-JP

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

Patient Problem Burn(s) (1757)

Event Date 03/25/2020

Event Type  malfunction  

Event Description

Patient was found to have burn on forehead from nirs sensor during first assessment.Mepilex was in place between patient's skin and sensor.Nirs sensor left off after assessment and wound consult was ordered.

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10055672
• MDR Text Key: 190970545
• Report Number: 10055672
• Device Sequence Number: 1
• Product Code: MUD
• 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: 04/10/2020

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: 5100C-JP
• Device Catalogue Number: 5100C-JP
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 DA