Events

Safety Alert for LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Mallinckrodt do Brasil Ltda..

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
    1007
  • Date
    2010-02-24
  • 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
    According to the record holder, the internal batteries (in conjunction with the battery system controller) may cause the internal battery controller to trigger the safety mode of the equipment and, as a consequence, turn on a high priority alarm. In this case the alarm would be triggered unnecessarily, which can lead to an incorrect decision making on the part of the users. Anvisa's Technovigilance Unit is following up on this case. #### UPDATE (07/04/2011): The company sent a communication to UTVIG / ANVISA (Expediente: 585270 / 10-6) informing the finalization of corrective actions. According to the company, all equipment at risk in Brazil (36 units) were corrected (battery replacement). The company sent copies of the Service Orders corresponding to the correction services. Related documents: NOTIVISA 2010.04.000814, Files 054579 / 10-1 and 585270 / 10-6.
  • Reason
    Failure associated with the battery and battery control system may cause undesired high priority alarm.
  • Action
    The record holder is replacing all revision D and E batteries used in LEGENDAIR ventilators. To the users of the product it is recommended: (1) Check the battery revision of your equipment; (2) If the equipment battery is in revision D or E, fill out the Battery Inspection Form and send it to the product registration holder. To access the Inspection Form and the detailed instructions on how to perform the battery check, see Appendix A of the alert on the UTVIG website (www.anvisa.gov.br/tecnovigilância/alertas).

Device

LEGENDAIR Pulmonary Ventilator. Anvisa Record: 80136710174.

Manufacturer

Mallinckrodt do Brasil Ltda.