FDA Adverse Event Malfunction Summary report: N

NUCLETRON-OLDELFT

MDR report key: 156433 · Received March 17, 1998

Report

Report Number
MW1013181
Event Type
Malfunction
Date Received
March 17, 1998
Date of Event
March 13, 1998
Report Date
March 17, 1998
Manufacturer
NECLETRON-OLDELFT CORP.
Product Code
KPQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PHYSICIST

Narratives

Description of Event or Problem · 1

ACCORDING TO THE RPTR, AN INCIDENT OCCURRED IN 05-1995 DUE TO A FAILURE OF A COMPONENT KNOWN AS A CRYDOM. THIS FIRST INCIDENT WAS NOT REPORTED SINCE THE MFR DETERMINED THE INCIDENT TO BE RELATED TO OPERATOR ERROR. THE MFR WAS TO HAVE CONTACTED THE FACILITY WITH STRATEGIES TO PREVENT FUTURE PROBLEMS, BUT NO SUCH CONTACT EVER TOOK PLACE. THE INCIDENT WHICH OCCURRED IN MARCH WAS ALSO DUE TO A CRYDOM FAILURE WHICH RESULTED IN TRANSISTOR CONTROL RELAYS SHORTING OUT. ACCORDING TO THE RPTR, HIS STAFF WAS IN THE PROCESS OF COMPLETING A PT SIMULATION WHICH INVOLVES BRINGING THE GANTRY BACK INTO NORMAL CONFIGURATION. A TECH "HEARD A CRASH" AND NOTED THE IMAGE INTENSIFIER HAD FALLEN TO THE FLOOR. AFTER INVESTIGATING THE INCIDENT, THE RPTR WAS ABLE TO DETERMINE THE PROBLEM. THE DRIVE MOTOR FOR THE IMAGE INTENSIFIER HAD DRIVEN BEYOND THE PROGRAMMED CONTROL LIMIT. THE GANTRY WENT BEYOND ITS NORMAL ZERO DEGREE CONFIGURATION TO FOUR DEGREES. THE IMAGE INTENSIFIER BROKE FROM ITS WELDED BRACKET WHEN THE SUPPORT ARM FRACTURED INTO 2 PIECES. THE IMAGE INTENSIFIER FELL TO THE FLOOR LANDING IN A VERTICAL POSITION. THE CAMERA WAS DESTROYED AND SMOKING. AN IMAGE INTENSIFIER HAS BEEN PLACED BACK ONTO THE MACHINE WITH A NEW BRACKET. THE MACHINE HAS NOT YET BEEN TESTED. ALTHOUGH NO PT OR STAFF INJURIES RESULTED FROM THIS INCIDENT, THE RPTR FEELS THIS INCIDENT REPRESENTS A MAJOR SAFETY HAZARD. THE RPTR FEELS THE SVC PROVIDED TO THE FACILITY HAS BEEN "PATHETIC" AND PERHAPS THE POOR SVC MAY HAVE CONTRIBUTED TO THE FAILURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NUCLETRON-OLDELFT SIMULIX-MC KPQ NECLETRON-OLDELFT CORP. 10T NI

Patients

Seq Age Sex Outcome Treatment
1 48 YR