MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRUMPF MEDICAL WALL MOUNT; LIGHT, SURGICAL, CEILING MOUNTED

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

Trumpf medical operating room led lights were installed with (b)(6) as light controls.The (b)(6) were mounted inside a bracket that does not vent off heat.(b)(6) batteries were swelling in the case inside the wall bracket.Fda safety report id # (b)(4).

• Brand Name: TRUMPF MEDICAL WALL MOUNT
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
• MDR Report Key: 12210748
• MDR Text Key: 263132100
• Report Number: MW5102692
• Device Sequence Number: 1
• Product Code: FSY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/15/2021

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• 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