Events

Alerte De Sécurité sur 12V 2,3 AH BATTERIES WITH ACID AND TRANSPORTATION LEAD MODEL AGILENT / HEWLETT-PACKARD 40488A. COMPONENTS USED ON M1205A V24 / 26CT MODELS OF THE AGILENT AND M1275A MONITORING SYSTEM OF THE HEWLETT-PACKARD TRANSPORT SYSTEM. CODES 990901 À 991231, 000101 À 000131, MANUFACTURED BETWEEN 1O. SEPTEMBER 1999 AND JANUARY 31, 2000.

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 PANASONIC INDUSTRIAL MEDICAL GROUP E DISTRIBUÍDAS PELA AGILENT TECHNOLOGIES INC. HEALTH CARE 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
    41
  • Date
    2001-05-04
  • 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
    After the 1o. low battery alarm - "recharge"! the batteries may not provide "at least 15 minutes" of patient monitor operation before deleting the monitor. agilent affirms that the models m1205a and m1257a operate normally on ac power, but can not be used for transportation unless they are connected to ac power. loss of time between the recharge battery alarm and the time to delete the monitor may not be sufficient to locate another energy source, resulting in transitional loss of monitoring data from the patient being transported. agilent started the voluntary removal day, april 25, 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED AGILENT'S VOLUNTARY REMOVAL LETTER ON APRIL 25, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THESE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. PREPARE AN INVENTORY OF BATTERIES AFFECTED BY THE DATE PRINTED IN BLACK INK, NEAR THE ELECTRICAL CONTACTS, AND BY THE MODEL NUMBER OF THE BATTERY, LOCATED IN THE MIDDLE OF THE LABEL. MONITORS THAT HAVE AFFECTED BATTERIES CAN BE IDENTIFIED BY THE LABELS IN FRONT OF THE MONITORS. AGILENT WILL REPLACE FREE OF CHARGED BATTERIES. TO REPLACE THESE CONTACT YOUR AGILENT REPRESENTATIVE OR THE UNITED STATES NATIONAL NOTIFICATION CENTER (00XX-1-880-668-4391 OR 934-7372). LIDE AND DISPOSE OF BATTERIES ACCORDING TO THE REQUIRED STANDARDS, KEEPING THE TESTS.

Device

12V 2,3 AH BATTERIES WITH ACID AND TRANSPORTATION LEAD MODEL AGILENT / HEWLETT-PACKARD 40488A. CO...

Manufacturer

PANASONIC INDUSTRIAL MEDICAL GROUP E DISTRIBUÍDAS PELA AGILENT TECHNOLOGIES INC. HEALTH CARE SOLU...
  • Source
    ANVSANVISA