To:

Medexcom Teh Srl

Cuza Voda, 44
Chisinau 2060
MOLDOVA

Monterotondo, Nov. 7th 2023

“MANUFACTURER REPORT”

FIELD INCIDENT HAPPENED AT EMERGENCY MEDICINE INSTITUTE IN CHISINAU ON OCTOBER 28th 2023.

From the analysis carried out on the machine, it was found that the impact occurred during a keypad table
lift command which was pressed by the operator while wanting actually to tilt the table in the - 90°
position. Due to a volumetric control parameter present in the control board and its configuration file
which was misregistered during installation with the correct volumetric value present on the command
console for vertical table movement interval, there was a delay of a few centimetres of the stop system,
causing the impact. This is evident from the fact that the machine stopped far from its final positions, and
far from the end-of-travel and extra-travel sensors, this means that the safety system intervened at the first
level.
The machine has 3 levels of safety to prevent from collisions and cause the machine to stop in the event of
impact conditions:

1. Position sensors with volumetric control of the overall dimensions of the machine during handling,
this control manages the movement, preventing the machine from reaching conditions of risk of
impact. This is a normal operating condition.
2. Position sensors that detect the presence of impact hazard limit condition. In this condition, every
movement of the machine is stopped and an error message appears to warn the operator of the
problem and allow him, after releasing the command, to return the machine to a normal operating
position.
3. Exceeding the minimum acceptable conditions. In this condition, the machine switches off
immediately and it is not possible for the operator to switch the machine back on (stroke exceeding
signal); A technician is required to restore normal operating conditions.

ASSING S.p.A.
Via E. Amaldi 14 \ 00015 Monterotondo (Roma) \ Italy
Tel. +39 06 906701 \ Fax +39 06 90670200 \ mail: sede@assing.it \ www.assing.it
Cap. Soc. € 2.500.000 \ P. Iva IT01603091008 \ C.F. 06725640582
In addition to the 3 levels of safety, near the keypads and the control console there are emergency buttons
to stop the machine immediately, when at least one of these is pressed by the operator in case of
emergency.

During our intervention, all the functions of the machine, the calibrations of the positions, the operation of
the control elements have been checked; above all, the parameter in the configuration file of the control
board has been updated to the correct value.
Considering the low ceiling height of the site, which in fact is outside the minimum recommended values
for normal installation conditions (2800 cm) and also considering potential clinical irrelevant movements of
the machine (such as too high table height movement) which could be requested by the operator, the
volumetric parameters of the system have been set to more precautionary values to avoid possible
collisions in the future. At the end of our intervention all the parameters have been rechecked and
verified, an in-depth testing of the system and possible movements in all operating conditions have been
conducted. The system is operating in safety conditions.

During the inspections, it was also found that sometimes the operators carry out incorrect and forced
procedures when switching on/off the machine, the repetition of which could cause damage of the pc
workstation in the future.

ASSING deems it appropriate for healthcare operators to carry out a new training session to correctly learn
how to turn on and off the equipment, the correct operating functions, safety and emergency devices of
the machine.
ASSING draws the attention to the fact that only authorised personnel who was trained by Medexcom-
The SRL or Assing has the right to do any manipulations of the system.

We remain at your disposal for any clarification you might need.

Best regards

Assing S.p.A.
Technical Director
Eng. Alessando Biasini
_________________

ASSING S.p.A.
Via E. Amaldi 14 \ 00015 Monterotondo (Roma) \ Italy
Tel. +39 06 906701 \ Fax +39 06 90670200 \ mail: sede@assing.it \ www.assing.it
Cap. Soc. € 2.500.000 \ P. Iva IT01603091008 \ C.F. 06725640582