Communication D'accidents Aux Gens - OMS ARCADIA EXT Mode D'emploi

10. COMMUNICATION D'ACCIDENTS AUX GENS

Dir. 93/42/CEE All. II (D.G. 2/1 Rev. 0)
NOM DU CLIENT _________________________________________________________________________________
ADRESSE _______________________________________________________________________________________
N° SERIAL DE L'EQUIPEMENT _______________________________________________________________________
DESCRIPTION DE L'ACCIDENT _______________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
DOMMAGES POUR LA SANTĖ DU PATIENT OU DE L'UTILISATEUR __________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
Date ___________________________________
Signature ________________________________
ESPACE RESERVE A LA SOCIETE (ASSURANCE QUALITE)
CAUSE POSSIBILE DE L'ACCIDENT:
Dysfonctionnement

 Détérioration des caractéristiques et/ou performaces
Insuffisance dans le mode d'emploi

Autre __________________________________________________________________________________________
GRAVITE DU DOMMAGE __________________________________________________________________________
_______________________________________________________________________________________________
DECISIONS OPERATIONNELLES PROPOSEES ___________________________________________________________
_______________________________________________________________________________________________
Date ____________________________________
Signature ________________________________
ESPACE RESERVE A LA SOCIETE (DIRECTIO GENERALE)
DECISIONS OPERATIONNELLES _____________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
ACTIONS CORRECTIVES ____________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
_______________________________________________________________________________________________
Date ____________________________________
Signature ________________________________
En cas d'accident envoyer le forme à O.M.S. S.p.A. le plus tôt possible. .
OMS ARCADIA EXT S.T.01/3R ED.0 REV.7 06/2017
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