DIGITALDIAGNOST 4.1 HIGH PERFORMANCE

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). THE DIGITALDIAGNOST R4.X IS A STATIONARY X-RAY SYSTEM INTENDED FOR GENERAL RADIOGRAPHIC IMAGING. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (SKYPLATE) CAN BE USED FOR IMAGE ACQUISITION. PHILIPS RECEIVED A COMPLAINT INDICATING THAT A FIRE HAD OCCURRED WITHIN THE HOSPITAL FACILITY OVER THE WEEKEND. AS A RESULT OF THE INCIDENT, SMOKE ENTERED THE ROOM WHERE THE PHILIPS SYSTEM WAS INSTALLED THROUGH CABLE DUCTS CONNECTED TO ADJACENT AREAS. AS A PRECAUTION, THE CUSTOMER DISCONNECTED THE ACQUISITION WORKSTATION (AWS) AND REQUESTED VERIFICATION OF THE SYSTEM BEFORE RETURNING IT TO SERVICE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT, AND NO PATIENT OR USER HARM WAS REPORTED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REINSTALLED THE ACQUISITION WORKSTATION (AWS). DURING SYSTEM STARTUP, AN ERROR INDICATED THAT COMMUNICATION WITH THE TABLETOP DETECTOR COULD NOT BE ESTABLISHED. INSPECTION CONFIRMED THAT THE AWS SHOWED NO EVIDENCE OF FIRE, SMOKE, CONDENSATION, OR PHYSICAL DAMAGE AND WAS FUNCTIONING NORMALLY. FURTHER TROUBLESHOOTING DETERMINED THAT THE TABLETOP DETECTOR WAS NOT RECEIVING POWER. DIAGNOSTIC TESTING CONFIRMED THAT THE TABLE BUCKY POWER SUPPLY WAS NOT PROVIDING OUTPUT VOLTAGE, WHILE THE COMMUNICATION CABLE BETWEEN THE SYSTEM AND THE TABLE WAS INTACT AND SHOWED NO EVIDENCE OF DAMAGE. INVESTIGATION DETERMINED THAT EXPOSURE TO HOT STEAM ENTERING THE ROOM FOLLOWING THE FACILITY INCIDENT MOST LIKELY RESULTED IN ELEVATED TEMPERATURES BENEATH THE TABLE, CAUSING FAILURE OF THE POWER SUPPLY SUPPLYING THE TABLETOP DETECTOR. THE DEFECTIVE POWER SUPPLY WAS REPLACED, COMMUNICATION WITH THE TABLETOP DETECTOR WAS RESTORED, AND THE SYSTEM RETURNED TO NORMAL OPERATION. FUNCTIONAL TESTING, DETECTOR VERIFICATION, AND MULTIPLE TEST EXAMINATIONS CONFIRMED THAT THE SYSTEM MET SPECIFICATIONS. A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THE CUSTOMER CONFIRMED THAT A BURNING SMELL WAS NOTICED DURING THE EVENT; HOWEVER, NO VISIBLE FIRE, FLAMES, OR SMOKE ORIGINATED FROM THE PHILIPS SYSTEM. THE ONLY SMOKE OBSERVED ENTERED THE ROOM THROUGH CABLE DUCTS FROM ADJACENT HOSPITAL AREAS, AND THE HOSPITAL FIRE ALARM WAS ACTIVATED DURING THE INCIDENT. NO EVIDENCE OF A SHORT CIRCUIT, OVERHEATING, FIRE INITIATION, OR ELECTRICAL FAILURE ORIGINATING FROM THE PHILIPS SYSTEM WAS IDENTIFIED DURING THE INVESTIGATION. THE CUSTOMER SUBSEQUENTLY CLARIFIED THAT NO FIRE HAD OCCURRED. INSTEAD, A PRESSURE RELIEF VALVE (PRV) FAILED, RELEASING HOT STEAM BENEATH THE ROOM. THIS WAS A FACILITY PLUMBING ISSUE UNRELATED TO THE PHILIPS SYSTEM OR ITS ELECTRICAL COMPONENTS. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION RESULTS, THE REPORTED EVENT WAS CAUSED BY FAILURE OF A FACILITY PRESSURE RELIEF VALVE, WHICH RELEASED HOT STEAM BENEATH THE ROOM AND RESULTED IN SMOKE AND HEAT ENTERING THE EXAMINATION ROOM. THIS EXTERNAL FACILITY EVENT MOST LIKELY CAUSED FAILURE OF THE TABLE BUCKY POWER SUPPLY. NO EVIDENCE WAS IDENTIFIED THAT THE PHILIPS SYSTEM INITIATED THE EVENT OR CONTRIBUTED TO THE FACILITY INCIDENT. THE EVENT WAS INITIALLY REPORTED BECAUSE INSUFFICIENT INFORMATION WAS AVAILABLE TO DETERMINE REPORTABILITY. ADDITIONAL INFORMATION OBTAINED DURING THE INVESTIGATION CONFIRMED THAT THE EVENT DOES NOT MEET THE APPLICABLE REPORTING CRITERIA.

Description of Event or Problem

IT WAS REPORTED THAT A FIRE INCIDENT HAD OCCURRED WITHIN THE HOSPITAL FACILITY OVER THE WEEKEND. AS A RESULT OF THE INCIDENT, SMOKE ENTERED THE ROOM WHERE THE PHILIPS SYSTEM WAS INSTALLED THROUGH CABLE DUCTS CONNECTED TO ADJACENT AREAS. AS A PRECAUTIONARY MEASURE, THE CUSTOMER DISCONNECTED THE ACQUISITION WORKSTATION (AWS) AND REQUESTED VERIFICATION OF SYSTEM FUNCTIONALITY BEFORE RETURNING THE EQUIPMENT TO SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT, AND NO PATIENT OR USER HARM WAS REPORTED.

Additional Manufacturer Narrative

REFERENCE ID: (B)(4). THE DIGITALDIAGNOST R4.X IS A STATIONARY X-RAY SYSTEM FOR GENERAL RADIOGRAPHIC PURPOSES. AS AN OPTION, A PORTABLE DIGITAL FLAT PANEL DETECTOR (MODEL "SKYPLATE") CAN BE USED FOR IMAGE CAPTURE. PHILIPS RECEIVED A COMPLAINT ON THE DIGITALDIAGNOST R4.X INDICATING THAT A FIRE HAD OCCURRED WITHIN THE HOSPITAL FACILITY OVER THE WEEKEND. AS A RESULT OF THE INCIDENT, SMOKE ENTERED THE ROOM WHERE THE PHILIPS SYSTEM WAS INSTALLED THROUGH CABLE DUCTS CONNECTED TO ADJACENT AREAS. AS A PRECAUTIONARY MEASURE, THE CUSTOMER DISCONNECTED THE ACQUISITION WORKSTATION (AWS) AND REQUESTED VERIFICATION OF SYSTEM FUNCTIONALITY BEFORE RETURNING THE EQUIPMENT TO SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT, AND NO PATIENT OR USER HARM WAS REPORTED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REINSTALLED THE AWS; HOWEVER, AN ERROR WAS OBSERVED INDICATING THAT COMMUNICATION WITH THE TABLETOP DETECTOR COULD NOT BE ESTABLISHED. INITIAL INSPECTION CONFIRMED THAT THE AWS SHOWED NO SIGNS OF FIRE, SMOKE, CONDENSATION, OR OTHER PHYSICAL DAMAGE AND WAS FUNCTIONING NORMALLY. FURTHER TROUBLESHOOTING IDENTIFIED THAT THE TABLETOP DETECTOR WAS NOT RECEIVING POWER. DIAGNOSTIC TESTING CONFIRMED THAT THE TABLE BUCKY POWER SUPPLY WAS NOT PROVIDING OUTPUT VOLTAGE (0 V), WHILE THE COMMUNICATION CABLE BETWEEN THE SYSTEM AND THE TABLE REMAINED INTACT AND SHOWED NO EVIDENCE OF FIRE-RELATED DAMAGE. ADDITIONAL INVESTIGATION CONFIRMED THAT THE ONLY AFFECTED PHILIPS COMPONENT WAS THE POWER SUPPLY SUPPLYING THE TABLETOP DETECTOR. THE DEFECTIVE POWER SUPPLY WAS REPLACED WITH A PHILIPS SPARE PART AVAILABLE AT THE CUSTOMER SITE. FOLLOWING REPLACEMENT, COMMUNICATION WITH THE TABLETOP DETECTOR WAS SUCCESSFULLY RESTORED, AND THE SYSTEM WAS RETURNED TO NORMAL OPERATION. FUNCTIONAL TESTING, DETECTOR VERIFICATION, AND MULTIPLE EXAMINATIONS WERE PERFORMED TO CONFIRM PROPER SYSTEM PERFORMANCE. A GOOD FAITH EFFORT (GFE) WAS SUBSEQUENTLY CONDUCTED TO OBTAIN ADDITIONAL DETAILS REGARDING THE INCIDENT. THE CUSTOMER CONFIRMED THAT A BURNING SMELL WAS NOTICED DURING THE EVENT; HOWEVER, NO VISIBLE FIRE, FLAMES, OR SMOKE ORIGINATED FROM THE PHILIPS SYSTEM. THE ONLY SMOKE OBSERVED ENTERED THE ROOM THROUGH CABLE DUCTS CONNECTED TO ADJACENT HOSPITAL AREAS AFFECTED BY THE FIRE. THE HOSPITAL FIRE ALARMS WERE ACTIVATED DURING THE INCIDENT. THE CUSTOMER FURTHER CONFIRMED THAT THE FIRE ORIGINATED EXTERNAL TO THE PHILIPS SYSTEM AND WAS RELATED TO HOSPITAL INFRASTRUCTURE. NO EVIDENCE OF SHORT CIRCUITS, OVERHEATING, FIRE INITIATION, OR ELECTRICAL FAILURE ORIGINATING FROM THE PHILIPS SYSTEM WAS IDENTIFIED DURING THE INVESTIGATION. INFORMATION REGARDING THE EXACT CAUSE OF THE HOSPITAL FIRE, INCLUDING ANY ASSOCIATED POWER FAILURE, POWER FLUCTUATION, OR INFRASTRUCTURE-RELATED ELECTRICAL EVENT, WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION AND REMAINS UNDER EVALUATION BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THE TABLETOP DETECTOR POWER SUPPLY FAILURE OCCURRED FOLLOWING THE HOSPITAL FIRE AND SUBSEQUENT SMOKE EXPOSURE. WHILE THE POWER SUPPLY WAS CONFIRMED TO HAVE FAILED, THE EXACT MECHANISM THAT CAUSED THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE FAILURE IS CONSIDERED MOST LIKELY ASSOCIATED WITH ENVIRONMENTAL CONDITIONS RESULTING FROM THE EXTERNAL HOSPITAL FIRE. REPLACEMENT OF THE POWER SUPPLY RESTORED FULL SYSTEM FUNCTIONALITY, AND NO FURTHER PRODUCT-RELATED ISSUES WERE IDENTIFIED. THE SYSTEM IS CURRENTLY FUNCTIONING AS INTENDED AND REMAINS IN CLINICAL SERVICE. INVESTIGATION IS IN-PROGRESS.

Description of Event or Problem

IT WAS REPORTED THAT A FIRE INCIDENT HAD OCCURRED WITHIN THE HOSPITAL FACILITY OVER THE WEEKEND. AS A RESULT OF THE INCIDENT, SMOKE ENTERED THE ROOM WHERE THE PHILIPS SYSTEM WAS INSTALLED THROUGH CABLE DUCTS CONNECTED TO ADJACENT AREAS. AS A PRECAUTIONARY MEASURE, THE CUSTOMER DISCONNECTED THE ACQUISITION WORKSTATION (AWS) AND REQUESTED VERIFICATION OF SYSTEM FUNCTIONALITY BEFORE RETURNING THE EQUIPMENT TO SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT, AND NO PATIENT OR USER HARM WAS REPORTED.