MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. BRILLIANCE 16 AIR; JAK

Model Number 728246

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this case a phillips field service engineer (fse) reported after moving a brilliance 16 ct system from one location in the hospital to another and installing it, fire and smoke came out of the teal transporter when the system was powered on.The fse reported there was smoke and visible fire.The fire was contained within the teal transformer and extinguished itself.The hospital's maintenance technicians appeared after the fire alarm was triggered.The fse confirmed there was no harm as a result of this issue and the building was not evacuated.The fse replaced the teal transformer to resolve the issue.

Manufacturer Narrative

We will file a follow-up mdr at the completion of the investigation.(b)(4).

Manufacturer Narrative

(b)(4).On (b)(6) 2014, a philips field service engineer (fse) reported that after moving a brilliance 16 ct system from one location in the hospital to another and installing it, fire and smoke came out of the teal transformer when the system was powered on.The fse reported there was smoke and visible fire.The fire was contained within the teal transformer and extinguished itself.The hospital's maintenance technicians appeared after the fire alarm was triggered.The fire department was not called.The fse confirmed there was no harm as a result of this issue and the building was not evacuated.The fse contacted the philips help desk to inform them of the issue.The fse checked the electrical connection in the electrical panel and replaced teal 100 kva isotran lm to resolve the issue.The device was not returned for evaluation.Since there were no parts returned from the field or log files provided, a probable cause of the issue could not be determined by engineering.However, based upon the troubleshooting services and statements of the fse, a probable cause was determined that the issue occurred due to the electrical connection in the electrical panel.The fse replaced teal 100 kva isotran lm to resolve the issue.The following mitigations for this issue include: compliance to iec 60601-1 3rd ed.Covers shall be constructed of non-flammable materials or materials containing additives for the prevention of fire spread and gas emissions, as per en 60601-1 and ul94-v0.Pcb¿s design and production under ul 94-0 or ul94v5 requirements.System software monitors x-ray tube heat status and prevents scanning that would result in unsafe condition.Design employs only ul and csa approved materials that meet iec 60601 and ul94 performance specifications.Processes and documentation for inspection, cleaning and replacement of air filters.Establish safe and effective procedures, training and documentation for scanner use regarding fluid containment hazards.The system shall provide a press-to-talk control to enable the operator voice transmission to the patient procedure room.Operator instructions to watch the patient during all movements.The ecg monitor and trigging is ce medical device certified.Full system ups has temperature sensor monitoring the battery cabinet temperature.Full system ups comes with operator interface unit to allow, when installed remotely, status notification on system (beep alarm for fault condition).Ups periodic maintenance service is offered to customers where, if declined, the customer is then responsible for maintenance including removing dirt and dust from the cabinet.(5) ups initial installation is performed as commissioning (vendor certified personnel verifying proper installation).The ups cabinet enclosure shall be made of flame-proof metal (non-flammable, self-extinguishing, fire resistant) and shall contain catastrophic occurrence.Ups installation specification requires emergency power off (epo) switch at operator station (beyond e-stop).Room ventilation requirements shall alleviate smoke build up in room.There are specific ventilation requirements for the electronic cabinet (forced air ventilation).In addition to local hv generator fusing of mains input, the system shall employ gantry fusing.Critical functions such as kv, ma, grid voltage and filament current from hv generator shall be controlled via system rhost pcb analog reference outputs to hv generator.Critical functions such as kv, ma, grid voltage and filament current shall be monitored via rhost pcb analog feedback inputs from hv generator.The sequencing and response of the x-ray system shall be monitored by the rhost to ensure safe operation.The rhost shall have the ability to open system e-stop, removing power from the hv generator and stopping production of x-rays in the event of a system and/or hv generator fault condition via the ¿shutdown¿ signal to the generator.The cpm enclosure shall be made of flame-proof metal material (non-flammable, self-extinguishing, fire resistant) and shall contain catastrophic occurrence.There shall be fusing at mains input to prevent over-current condition.Fusing shall be employed in line monitor circuitry.All pc boards design shall comply with ul 94v-0.Lexan and fr4 (plastic) components within cpm shall be ul 94v-0 rated or better.Inverter modules inside the cpm shall be forced air cooled.Cpm inverter module shall employ temperature sensing that prevents high voltage production when threshold temp is exceeded.Cpm potting material used in high voltage output stage shall be ul 94v-0 compliant.Cpm high voltage transformer materials and encapsulate shall be ul 94v-0 compliant.A pc board baking/drying process shall be employed after washing to prevent moisture infiltration into metal film capacitors, and potential failures.Electronic overload circuits for voltage and current shall be employed to sense an overload condition and to shut down the hv power supply.

• Brand Name: BRILLIANCE 16 AIR
• Type of Device: JAK
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.; 595 miner rd.; cleveland OH 44143
• Manufacturer Contact: kumudini carter ; 595 miner rd; mr training department; cleveland, OH 44143 ; 4404833032
• MDR Report Key: 4347535
• MDR Text Key: 5176831
• Report Number: 1525965-2014-00198
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K012009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728246
• Device Catalogue Number: NCTA399
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1