Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PANASONIC INDUSTRIAL MEDICAL GROUP E DISTRIBUÍDAS PELA AGILENT TECHNOLOGIES INC. HEALTH CARE SOLUTIONS GROUP.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    41
  • Date
    2001-05-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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