CP1000

Additional Manufacturer Narrative

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Description of Event or Problem

AN EVENT OF A FIRE INVOLVING A CP1000 UNIT OCCURRED AT THE SITE ON (B)(6) 2016. THE DEALER REPORTED TO AGFA ON MAY 11, 2016, THAT THE CP1000 UNIT WAS INVOLVED IN A FIRE. THE UNIT WAS INSTALLED 1.5 YEARS AGO AND THE LAST SERVICE ACTIVITY WAS ON APRIL 6, 2015. THE UNIT WAS WORKING AS INTENDED BEFORE THE FIRE OCCURRED. THE AFFECTED DEVICE IS SOLD AND MAINTAINED BY A THIRD PARTY DEALER. AGFA WILL PROVIDE A REPLACEMENT UNIT TO THE CUSTOMER. THE ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. POTENTIAL CAUSES CAN BE: OVERHEATING OR SHORT CIRCUIT OF COMPONENTS CAN CAUSE MELT DOWN AND SMOKE DEVELOPMENT OR FIRE. LEAKING OF CHEMICALS ON ELECTRICAL COMPONENTS CAN CAUSE SMOKE DEVELOPMENT OR FIRE TO THE DEVICE. AN EXTERNAL SOURCE (HEAT/FLAME) CAN CAUSE SMOKE DEVELOPMENT OR FIRE TO THE DEVICE. SEVERAL SAFETY PRECAUTIONS HAVE BEEN LISTED IN THE "REFERENCE MANUAL" OF THE DEVICE TO PREVENT THE ABOVE MENTIONED CONDITIONS. ADDITIONALLY, AGFA REQUIRES INSTALLATION OF A GFI (GROUND FAULT INTERRUPTER) 30 MA-TYPE FOR BOTH PEOPLE AND FIRE PROTECTION IN CASE OF A POTENTIAL INCIDENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THIS EVENT. PICTURES HAVE BEEN PROVIDED TO SHOW VISUAL PROPERTY DAMAGE.

Additional Manufacturer Narrative

SERIAL # WAS CORRECTED FROM (B)(4). DURING THE INVESTIGATION BY AGFA, BETWEEN 06/20 - 07/04, THE ROOT CAUSE WAS IDENTIFIED. THE ANALYSIS OF THE REMAINDERS SHOWED THE CP1000 WAS SUBJECTED TO THE FIRE BUT NOT THE SOURCE OF THE FIRE. THERE HAVE BEEN NO REPORTS OF HARM TO USERS OR PATIENTS DURING THESE EVENTS.

Description of Event or Problem

THE SERIAL NUMBER PROVIDED WAS INCORRECT. THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECT SERIAL NUMBER AND THE ROOT CAUSE.