Events

Alerte De Sécurité sur HEWLETT-PACKARD STERILIZABLE DEFIBRILLATION OPERATORS: (1) MODEL M14986B, (2) MODEL M1748A

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 AGILENT TECHNOLOGIES HEALTHCARE SOLUTIONS GROUP.

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
    143
  • Date
    2000-06-13
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    An ecri member hospital reported that the defibrillation machines mentioned developed fissures and lasks through their borders as they were reterproofed in the time.
  • Action
    ECRI MAKES THE FOLLOWING RECOMMENDATIONS: (1) NOTIFY EMPLOYEES ABOUT THE PROBLEM, REMEMBER THAT THESE DEFIBRILLATION OPERATORS HAVE LIFE OF APPROXIMATELY 200 STERILIZATIONS AND ARE UNDER WARRANTY FOR 1 YEAR. IN ADDITION, ENSURE THAT THE DEFIBRILLATION ACTUATORS MADE BEFORE 1O. OF MARCH OF 1999 MAY BE MORE SUSCEPTIBLE TO FISSURES AND LASKS THAT MOST RECENT MODELS. (2) FOLLOW THE MANUFACTURER'S STERILIZATION GUIDELINES. (3) REPORT TO ANVISA AND THE MANUFACTURER IN CASE OF FISSURES AND LASKS APPEAR WITHIN THE WARRANTY PERIOD OF THE DEFIBRILLATION ACTUATOR SETS MADE AFTER 1O. OF MARCH 1999. (4) REPAIR ANY STERILIZABLE DEFIBRILLATION ACTUATOR SO THAT THEY REPEAT FISSURES OR LASKS AFTER REHOSTERILIZATION. (5) IF THE POSSIBILITY OF A PATIENT IS NECESSARY TO NEED DEFIBRILLATION DURING A PROCEDURE, CONSIDER PLACING DISPOSABLE ADHESIVES IN THE PATIENT BEFORE THE BEGINNING OF THE OPERATION BEFORE USING EXTERNAL DEFIBRILLATION PARTS. THIS WILL REDUCE THE NUMBER OF STERILIZATIONS OF THE DEFIBRILLATION ACTUATORS.

Device

HEWLETT-PACKARD STERILIZABLE DEFIBRILLATION OPERATORS: (1) MODEL M14986B, (2) MODEL M1748A

Manufacturer

AGILENT TECHNOLOGIES HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA