FDA Adverse Event Injury Summary report: N

MCT 100/480 ISOLATION TRANSFORMER ACCESSORY TO THE CT

MDR report key: 962444 · Received December 6, 2007

Report

Report Number
MW5004622
Event Type
Injury
Date Received
December 6, 2007
Date of Event
November 9, 2007
Report Date
December 6, 2007
Manufacturer
PHILIPS MEDICAL SYSTEMS, INC
Product Code
KPS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AT 4:15 P.M, A FIRE CONSUMED THE TRANSFORMER UNIT ATTACHED TO THE CT SCANNER IN OUR STREET LOCATION. AT THE SAME TIME, THE MEDICAL IMAGING SYSTEMS - ENGINEER WAS IN THE CT ROOM PERFORMING MAINTENANCE. FIRE DEPARTMENT ARRIVED AND EXTINGUISHED FIRE, WITH A SIGNIFICANT AMOUNT OF DAMAGE TO ROOM, CEILING, VENTILATION HANDLERS ETC. INSURANCE WAS CALLED ON BEHALF OF CLINIC. POLICY WAS WRITTEN. THREE DAYS LATER, RECEIVED A DETAILED INCIDENT REPORT FROM MIS OUTLINING THE FIRE, AND OTHER INFORMATION RELATED TO THE PHILLIPS MEDICAL DEVICE RECALL FOR THE TRANSFORMER, OR POWER CONDITIONING UNIT. THE SAME DAY, INVESTIGATOR CONTRACTED, INVESTIGATOR ARRIVED TO REVIEW THE SCENE, COLLECT PHOTOGRAPHS, AND ASSESS DAMAGES. IMMEDIATELY FOLLOWING THE VISIT FROM THE INVESTIGATOR, ARRIVED WITH NO NOTICE TO LOOK AT THE ROOM, COLLECT PHOTOGRAPHS, AND ASSESS DAMAGE. DURING THIS VISIT HE WAS ESCORTED BY ME. HE TOLD ME THAT HE HAD NEVER SEEN ANYTHING THIS BAD. ADDITIONALLY, WHEN ASKED ABOUT THE RECALLED DEVICE, HE QUICKLY STATED THAT PHILLIPS HAD BEEN TO OUR SIGHT IN AUGUST, 2007 AND CLEARED US FOR THAT RECALL. WE HAVE NO RECORD OF THAT VISIT. CLEAN UP AND ROOM REPAIRS BEGAN WITH OVERSIGHT BY CLINIC STAFF. THE FOLLOWING DAY, INVESTIGATOR CONTACTED ME, ADVISING THAT PHILLIPS WAS OVERNIGHTING A NEW TRANSFORMER TO CLINIC. WHEN IT ARRIVED, THEY WOULD SUPPLY AN ENGINEER AND ELECTRICIAN TO INSTALL THESE ITEMS. ON THREE DAYS LATER, WE RECEIVED A CONTACT FROM ATTORNEYS, REQUESTING THAT WE SURRENDER THE BURNED TRANSFORMER TO THE INVESTIGATOR. WE DID SO. ON THE FOLLOWING DAY, THE NEW TRANSFORMER ARRIVED AND WAS INSTALLED BY THE PHILLIPS CONTRACTORS. HOWEVER, THE CT WOULD NOT COME "ON-LINE" DUE TO MORE REQUIRED PARTS. ON THREE DAYS LATER, MORE PARTS ARRIVED AND WERE INSTALLED BY THE PHILLIPS CONTRACTORS. THEY WERE ABLE TO BRING THE CT "ON-LINE" AND PERFORM A TEST SCAN. DURING THIS INITIAL TESTING, THERE WAS AN ENGINEER FROM MIS PRESENT, HOWEVER, OBSERVING ONLY. WHEN THE MIS ENGINEER REQUESTED THAT A "SYSTEMS PERFORMANCE TEST" BE COMPLETED AND RESULTS PROVIDED, THE PHILLIPS ENGINEER REFUSED. IT WAS STATED THAT MIS WOULD NEED TO PERFORM CALIBRATION THE FOLLOWING DAY BEFORE THE SCANNER WOULD BE READY TO USE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MCT 100/480 ISOLATION TRANSFORMER ACCESSORY TO THE CT TEAL POWER CONDITIONING UNIT KPS PHILIPS MEDICAL SYSTEMS, INC 4450028-01

Patients

Seq Age Sex Outcome Treatment
1 YR