FDA Adverse Event Malfunction Summary report: N

ULTRA MD CO2 LASER SYSTEM

MDR report key: 3941061 · Received April 24, 2014

Report

Report Number
3000204219-2014-00002
Event Type
Malfunction
Date Received
April 24, 2014
Report Date
April 24, 2014
Manufacturer
LASER ENGINEERING, INC.
Product Code
GEX
PMA / PMN Number
K905676
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

LASER ENGINEERING WAS NOTIFIED BY THE HOSPITAL FACILITY THAT THE ULTRA MD60 SERIAL (B)(4) HAD TO BE REMOVED FROM THE OPERATING ROOM BECAUSE OF SMOKE FROM THE LASER. WE WERE ALSO TOLD THAT NO PATIENT OR STAFF WERE INVOLVED OR HARMED. LASER ENGINEERING STARTED MAKING PLANS TO EVALUATE THE EQUIPMENT AT THE HOSPITAL FACILITY IMMEDIATELY LASER ENGINEERING SENT AN INVESTIGATIVE TEAM TO THE FACILITY ON (B)(4) 2013, AND THEY COULD NOT DETERMINE WHAT HAD CAUSED THE FIRE. THE LASER WAS CRATED AND RETURNED TO OUR FACTORY WHERE IT COULD NOT BE DETERMINED THE CAUSE OF THE FIRE . IT APPEARS THAT COOLANT MAY HAVE LEAKED ONTO THE HIGH VOLTAGE POWER SUPPLY, HOWEVER THERE WERE NO LEAKS DURING THE TRANSPORT OR DURING OUR EVALUATION . .PAST SERVICE REPORTS SHOW NO REFERENCE TO A COOLANT LEAK. WE DID DISCOVER THAT THE LAST SERVICE WAS PERFORMED BY A TECHNICIAN THAT HAD NOT BEEN FACTORY TRAINED. CONVERSATIONS INDICATE THAT THE TOWER COVER WHICH HAS TO BE REMOVED TO LOCATE ANY LEAKS WAS NOT REMOVED. WE HAVE NO WAY TO VERIFY WHAT ACTUAL WORK WAS COMPLETED DURING THE LASER SERVICE WHICH WAS APPROXIMATELY ONE MONTH PRIOR TO THE REPORTED INCIDENT. FULL DETAILS OF OUR INVESTIGATION ARE ON SITE AT LASER ENGINEERING, INC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
248497 ULTRA MD CO2 LASER SYSTEM ULTRA MD60 GEX LASER ENGINEERING, INC. MD60 NA

Patients

Seq Age Sex Outcome Treatment
1