Events

Safety Alert for DESFIBRILLATORS / EXTERNAL MARCAPASSO ZOLL M NOS. OF SERIES T00 (A) 08348, 08349, 08892, (B) 09016, 09176, 09255, 09256, 09298, 09300, 09307, 09308, 09313 To 09344, 09346 To 09353, 09355 To 09364, 09366 To 09373, 09376 To 09379 , 09381, 09382, 09387, 09391 Ã 09394, 09396 Ã 09406, 09408 Ã 09414, 09416 Ã 09424, 09426 Ã 09429, 09431 Ã 09438, 09440 Ã 09460, 09482 Ã 09485, 09576, 09577, 09579, 09581, 09709 Ã 09713, 09715, 09716, 09718, 09721, 09723, 09730, 09732, (C) 09743, 09756, 09851, 09984, 09985, 09988, 09989, 09991 À 09993, 10003 À 10005, 10203, 10232 À 10234, 10236 À 10240 , 10302, 10303, 11694, 11703, 11718, 11892, 11960, 11964, 11965, 12294.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ZOLL MEDICAL CORP..

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
    6
  • Date
    2001-03-14
  • 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
    07/18/2001 - BRAZIL - THE COMPANY COMERCIAL MEDICA LTDA, INFORMES THAT THE IMPORTATION OF THE SERIES AFFECTED TO BRAZIL WAS NOT OCCURRED. IT FURTHER INFORMES THAT, AT INTERNATIONAL LEVEL THE PROBLEM WAS RESOLVED AND COMMUNICATED TO THE FDA.
  • Reason
    May cause insufficient discharge of energy to patients with transtorcaic impedance <30 phms.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON 13 / DECEMBER / 2000. IDENTIFY AND INSULATE THE PRODUCT. ZOLL RECOMMENDS: (1) ALERT OPERATORS OF POSSIBLE DYSFUNCTION. (2) IF ANOTHER PRODUCT IS NOT AVAILABLE, RENT ONE AND REMOVE THE PRODUCT OF THE USE, UNTIL IT IS TESTED. IF NEEDED SERVICES OR FOR FURTHER INFORMATION, TELEPHONY TO ZOLL, 00XX1 (781) 229-0020.

Device

DESFIBRILLATORS / EXTERNAL MARCAPASSO ZOLL M NOS. OF SERIES T00 (A) 08348, 08349, 08892, (B) 0901...

Manufacturer

ZOLL MEDICAL CORP.
  • Source
    ANVSANVISA