Alerte De Sécurité sur ASSEMBLY EQUIPMENT FOR: (1) CONTRAST INJECTORS, (2) EXPLANATION LIGHTS, (3) PHOTOTHERAPY UNITS, (4) RADIATION PROTECTORS IDENTIFIER:

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    130
  • Date
    2000-09-22
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Ecri has received failure reports from the assembly equipment which result in the equipment collapse or in the injury / involvement of patients or team members. fault reports included cracking of arm bracket or bracket of bracket machine. ecri affirms that these faults of the mounting equipment are generally resulting from inadequate decisions of installation, defective equipment or lower quality, misuse of equipment or wear and normal break.
  • Action
    ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) REPORT TO EMPLOYEES THAT ASSEMBLING EQUIPMENT MAY FAIL AND CAUSE CORPORATE INJURY (2) DEFINE WHICH DEPARTMENT SHALL BE RESPONSIBLE FOR ROUTINE INSPECTIONS AND PREVENTIVE MAINTENANCE, AND REPORT THE EVIDENCE OF DAMAGE TO ASSEMBLY EQUIPMENT A THIS DEPARTMENT. (3) REPORT TO EMPLOYEES THAT THE ASSEMBLY EQUIPMENT MAY BE DAMAGED BY ITS BRUSK / UNUSED USE AND THAT THIS MUST BE HANDLED AS CAREFULLY AS MUCH AS THE MEDICAL EQUIPMENT AFFECTED IN IT. (4) INSPECT THE INSTALLATION OF THE MOUNTING EQUIPMENT TO ENSURE THAT STRUCTURES AND SUITABLE COMPONENTS ARE USED. (5) TURN THE ASSEMBLY EQUIPMENT INSPECTION PART OF THE INSPECTION ROUTINE OF ITS INSTALLATIONS AND ITS PREVENTIVE MAINTENANCE PROGRAM

Manufacturer

N/A
  • Source
    ANVSANVISA