Events

Safety Alert for Product name: Renasys GO Power Adapter and Power Cable Negative Wound Pressure Therapy - Portable - Product registration number on Anvisa: 80804050154 - Hazard Class: Class II - Affected Model (s): All serial number 144500875

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Smith & Nephew Comércio de Produtos Médicos 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
    1837
  • Date
    2016-03-18
  • 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
    The company describes that "after reviewing the complaints data related to external power units, smith & nephew has identified that some external power units may overheat and cause electric shock when used with renasys go negative pressure therapy . only certain external power units are affected by this problem. this field action only covers external power units and not renasys go negative pressure therapy pumps or the power cables that connect the external power supply unit to the power supply. ".
  • Action
    Correction in field / exchange of external power supply units of RENASYS GO equipment. Type of field action: class III, field correction; II. Field Action Code: 001/2016; III. Recommendations to Users and Patients: a. Users are instructed to immediately disconnect all affected external power units from the power source. B. The pump will continue to ensure Negative Pressure Therapy treatment until the device's internal battery runs out. w. Users should switch to an unaffected external power unit while the device is in battery mode to prevent interruption of Negative Pressure therapy. Negative Pressure therapy will no longer be supplied by the pump as soon as the RENASYS GO internal battery runs out. d. If an unaffected external power supply is not available, patients should consult their health care provider to determine an alternative treatment. and. Users should not use non-Smith & Nephew external power units with the RENASYS GO Negative Pressure Therapy Pump. LETTER TO THE CUSTOMER IN ANNEX.

Device

Product name: Renasys GO Power Adapter and Power Cable Negative Wound Pressure Therapy - Portable...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.