MAUDE Adverse Event Report: KBL AG KBL TOWER PURE ENERGY; SUNLAMP PRODUCT

Model Number	TOWER PURE ENERGY
Medical Device Problem Codes	Fire (1245); Electrical Overstress (2924)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Sunbed caught fire.
Event or Problem Description
Sunbed caught fire.

• Brand Name: KBL TOWER PURE ENERGY
• Common Device Name: SUNLAMP PRODUCT
• Manufacturer (Section D): KBL AG; ringstrasse 24-26; dernbach, rlp 56307 ; GM 56307
• MDR Report Key: 6672554
• Report Number: 3006116732-2017-00007
• Device Sequence Number: 9311962
• Product Code: LEJ
• Combination Product (Y/N): N
• PMA/510(K) Number: K151962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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
• Operator of Device: No Information
• Device Model Number: TOWER PURE ENERGY
• Device Catalogue Number: TOWER PURE ENERGY
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1