OMS ARCADIA EXT - 10. Accident Reporting

OMS ARCADIA EXT S.T.01/3R ED.0 REV.8 09/2020
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10. REPORTING ACCIDENTS TO PEOPLE
Dir. 93/42/CEE All. II (D.G. 2/1 Rev. 0)
CUSTOMER NAME _______________________________________________________________________________
ADDRESS _______________________________________________________________________________________
SERIAL NUMBER OF DEVICE ________________________________________________________________________
ACCIDENT ______________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
DAMAGE TO THE PATIENTS OR USER HEALTH _________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
Date ____________________________________
Signature ________________________________
Space reserved for the company (Quality assurance)
Possible cause of the accident:
 Malfunction
 deterioration of characteristics and/or performance
Shortage of operating instructions
Other __________________________________________________________________________________________
Damage ________________________________________________________________________________________
_______________________________________________________________________________________________
Proposed operational decisions _____________________________________________________________________
_______________________________________________________________________________________________
Date ____________________________________
Signature ________________________________
Space reserved for the Company (Directorate General)
Operational decisions _____________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
Corrective actions ________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
Date ____________________________________
Signature ________________________________
In case of an accident send the form to O.M.S.. with the maximum priority.