TREX PMT 6600 TM 802

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-24 for TREX PMT 6600 TM 802 manufactured by Trex Medical Corp. Xre Div..

Event Text Entries

[172721] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1018990
MDR Report Key279373
Date Received2000-05-24
Date of Report2000-05-22
Date of Event2000-05-16
Date Added to Maude2000-05-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTREX PMT 6600
Generic NameTOMOGRAPHY X-RAY SYSTEM
Product CodeIZF
Date Received2000-05-24
Model NumberTM 802
Catalog NumberPMT 6600
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key270387
ManufacturerTREX MEDICAL CORP. XRE DIV.
Manufacturer Address300 FOSTER ST LITTLETON MA 01460 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-05-24

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