FDA Adverse Event Other Summary report: N

TREX PMT 6600

MDR report key: 279373 · Received May 24, 2000

Report

Report Number
MW1018990
Event Type
Other
Date Received
May 24, 2000
Date of Event
May 16, 2000
Report Date
May 22, 2000
Manufacturer
TREX MEDICAL CORP. XRE DIV.
Product Code
IZF
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

ON MAY 16, 2000, THE TREX PMT6600 COMPUTER CONTROLLED TOMOGRAPHY SYSTEM MADE SEVERAL UNCONTROLLED TUBE HEAD MOVEMENTS. WHILE SETTING UP THE SYSTEM FOR AN ERECT-POST VOID WITH THE WALL BUCKY, THE TUBE CRASHED ONTO THE TABLE REPEATEDLY. THE RADIOLOGIST TECH TRIED TO STOP THE TUBE MOVEMENT BY GRABBING THE COLLIMATOR. THIS DID NOT STOP THE TUBE FROM DRIVING UP AND DOWN INTO THE TABLE. WHEN THE UNIT WAS TURNED OFF, MOVEMENT FINALLY STOPPED. THERE WAS NO PT INJURY. THE PMT 6600 WAS INSTALLED 8/6/99 AND IS STILL UNDER WARRANTY. THE LOCAL TREX MEDICAL REP INSPECTED THE EQUIPMENT AND FOUND THE SOFTWARE AT FAULT. NEW SOFTWARE WAS INSTALLED 5/16/00. THE FOLLOWING MORNING THE SYSTEM CRASHED INTO THE TABLE AGAIN WHILE PREPARING FOR A TOMOGRAPHIC PROCEDURE. THE SYSTEM WAS REMOVED FROM SVC UNTIL 5/18/00. TREX PROVIDED UPGRADED SOFTWARE VERSION 2.2.1 THAT ADDRESSES INVOLUNTARY MOVEMENT OF PMT 6600 AND ASSOCIATED TUBE STANDS. THE ROOM WAS RETURNED TO SVC 5/18/00. THIS IS THE 4TH INCIDENT OF INVOLUNTARY DRIVE/UNCONTROLLED MOVEMENT OF THE OVER TABLE TUBE WITH THE SYSTEM UNDER WARRANTY. EACH INCIDENT HAS BEEN INVESTIGATED BY THE VENDOR AND RESULTED IN THE INSTALLATION OF NEW SOFTWARE AND CALIBRATION OF THE SYSTEM. THE DATES OF EACH INCIDENT ARE: 1. 9/23/99, TUBE CAME DOWN ON PT. NO INJURY REPORTED. VENDOR CHECKED OUT SYSTEM AND ADVISED TECHS NOT TO USE THE "AUTO ON" FUNCTION WHEN THEY ARE OUT OF THE ROOM. TREX MEDICAL WAS NOTIFIED BY VENDOR. 2. 9/28/99, OVERHEAD TUBE DROVE INTO THE TABLE. VENDOR INVESTIGATED AND RELOADED SOFTWARE. 3. 10/6/99, OVERHEAD TUBE AGAIN DROVE INTO TABLE. VENDOR CHECKED OUT UNIT AND RELOADED SOFTWARE AGAIN. 4. 5/18/00 TREX MEDICAL PROVIDED VERSION 2.2.1 SOFTWARE THAT WAS INSTALLED BY VENDOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TREX PMT 6600 TOMOGRAPHY X-RAY SYSTEM IZF TREX MEDICAL CORP. XRE DIV. TM 802 *

Patients

Seq Age Sex Outcome Treatment
1 * Other