Events

Safety Alert for Pulmonary Ventilator Esprit V-100. Anvisa Registration No. 80102510035. Units at Risk: All Esprit V1000 manufactured before December 31, 2004 and Esprit V1000 manufactured prior to Dec 31, 2004 and converted to Esprit V200.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Respironics Califórnia, Inc (Philips Respironics)..

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
    1471
  • Date
    2014-12-01
  • 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
    The product manufacturer (Philips) has found that the fan hardware mounting screw of the Esprit V1000 and Esprit V200 fans may have been improperly installed, which may cause the end of the screw to touch the printed circuit board (PCBA) and cause a short circuit. This may prevent the ventilator from receiving battery power if the AC power (outlet) is interrupted. There is an auditory alarm on the equipment programmed to be triggered in a situation like this, alerting the medical staff about the loss of energy. Loss of energy in this situation may cause loss of the auxiliary ventilator, which could lead to hypercarbia or hypoxemia.
  • Reason
    Incorrect mounting of the power supply fan screws can cause them to touch the pcba, causing a short circuit and consequently preventing the switch to the battery (dc) when necessary.
  • Action
    Field correction. The use of the equipment may be continued, but the user should pay attention to the following: (a) be alert for the occurrence of the emergency alarm, which should sound loud and alert that the equipment can not operate via battery; (b) ensuring that alternative forms of ventilation (resuscitator or similar apparatus) are available when the ventilator is in use in a patient; and (c) patients on life-support equipment should be visually monitored by the competent medical staff, as life-threatening conditions that do not trigger the alarm may occur. Follow the instructions in the Operator's Manual and always check life support equipment before using them.

Device

Pulmonary Ventilator Esprit V-100. Anvisa Registration No. 80102510035. Units at Risk: All Esprit...

Manufacturer

VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Respironics Califórnia, Inc (Ph...
  • Source
    ANVSANVISA