Alerta De Seguridad para Zoll M Series Defibrillators. Paddles manufactured before September 1999; units distributed in the USA and internationally

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Zoll Medical Corp.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Brazil - 15.04.2002 - The commercial company Medica, which holds the national registry, has informed that up to the present date no similar incident has been detected or reported. For more information, contact your local representative at (011) 5561 2236
  • Causa
    An ecri member hospital has reported (reported) that in 3 of its zoll m series defibrillators, the cable connecting the external paddles of the defibrillators disconnected without the release button being tightened. this incident prevented the defibrillator from monitoring or shocking patients during resuscitation. there was no discomfort in the patient, but this problem could result in the death of the patient due to delays during the resuscitation efforts. zoll has developed the m series defibrillators so that the interface disconnects only if the force with which they are pulled is greater than 7 kilograms, which prevents the connection cables from breaking. however, the disconnections announced to ecri are likely to have occurred with forces of less than 7 kilograms. improper cable connection or disconnection produces audiovisual messages of check pads and pad contact, which can cause delays in identifying and correcting the true problem.
  • Acción
    Zoll is aware of the M Series cable connection problem and has identified two major causes of this problem: (1) the size of the input connector may be larger than that because the top paddle cover is separate from the paddle body. (2) the locking mechanism may be damaged because the defibrillator or paddle has fallen or been hit on a hard surface. Zoll announces that it has corrected the first problem by increasing the size of the boards that hold the top cover and the body of the paddle together. This change was implemented in paddles manufactured after September 1999, beginning with U991 Series number. Zoll announces that this has resulted in fewer reports of disconnection of the paddles. ECRI recommends that hospitals educate their staff on the proper use of Zoll M Series defibrillators and paddles and that they monitor the performance of the teams, making sure the product is not being abused or mistreated. Hospitals should also inspect the connectors by pulling the cables lightly while the connector is inserted into the paddle to see if it disconnects. If you disconnect, contact your local representative or directly with Zoll's technical department in the USA at 1 (781) 229-0020. For more information, contact the ANVISA Technovigilance Unit, by e-mail or by telephone (61) 448-1485.


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