Events

Alerte De Sécurité sur HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE

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 INC. 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
    31
  • Date
    2001-04-14
  • 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
    The data and time of the filed data (wav registry, trends analysis, events and alarm reviews) of the system with the b.00.23 version and b.01.06 of the software are frequently wrong, with the vic showing variations of date and time of some of my.
  • Action
    ECRI RECOMMENDS THE FOLLOWING: (1) ALERT THE USERS OF THESE CENTRAL AND ALL RELEVANT STAFF OF THE PROBLEM REFERENCED ABOVE WITH THE AUTOMATIC SWITCH TAKES FOR THE ALARMS AND SOFTWARE VERSIONS. (2) CONTACT YOUR AGILENT TECHNICAL REPRESENTATIVE TO SCHEDULE THE SOFTWARE EXCHANGE BY UPDATING (VERSION C). (3) UNTIL THE NEW VERSION IS INSTALLED AND CHECKED, THERE ARE TWO POSSIBLE ALTERNATIVES TO ADMIT OR TRANSFER A PATIENT: 1A. OPTION - FOR USE AS A MONITOR OF THE BED OR TRANSMITTED BY TELEMETRY - 10. TURN OFF THE MONITOR AND REMOVE THE BATTERY OF THE TELEMETRY TRANSMITTER, BEFORE CONNECTING IT TO THE PATIENT; 2O. CONNECT THE PATIENT TO THE MONITOR OR TELEMETRY TRANSMITTER, TURN ON THE MONITOR OR INSERT THE BATTERY ON THE TELEMETRY TRANSMITTER AND ENSUIT OFF THE "WAIT" CHOICE ON THE CENTRAL STATION; 3O. IMMEDIATELY AFTER, ADMIT THE PATIENT TO VIC. A 2A. OPTION - FOR USE WITH LIGHT MONITOR ONLY - 10. BEFORE CONNECTING A PATIENT, PLACE THE MONITOR IN THE "WAIT" MODE AND ADMIT THE PATIENT TO THE VIC; 2O. CONNECT THE PATIENT TO THE MONITOR AND REACTIVATE THE MONITOR, MAKE SURE THE MONITOR IS NO LONGER IN THE "WAIT" MODE! ECRI PREFER RECOMMENDS 2A. OPTION WITH LIGHT MONITOR, THAT IT SEEMS TO INDICATE TIME AND DATE WITH LESS LEVEL OF VARIATION, WHILE IN 1A. OPTION, ANY INTERVAL BETWEEN CONNECTION AND ADMISSION TO VIC MAY ALLOW THE OCCURRENCE OF VARIATIONS.

Device

HEWLETT PACKARD VIRIDIA INFORMATION CENTER, MONITORING SYSTEM SOFTWARE

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA