MAUDE Adverse Event Report: TRUMPF MEDICAL SYSTEMS ILED7; LIGHT, SURGICAL

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/11/2017

Event Type  Injury  

Event Description

Patient having open heart surgery under trump filed7 operating room light for a 4-5 hour case.Patient sustained a partial thickness burn to the chest wall near the incision that was evident after the drapes were removed.

• Brand Name: ILED7
• Type of Device: LIGHT, SURGICAL
• Manufacturer (Section D): TRUMPF MEDICAL SYSTEMS; charleston SC 29492
• MDR Report Key: 7142176
• MDR Text Key: 95732441
• Report Number: MW5074186
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 12