Safety Alert for Trade name: Patient lift. Technical Name: Patient Lift. ANVISA registration number: 80259110103. Class of risk: - Low Risk. Model Affected: Maximove. Serial numbers affected: 300044700; 300070780-300070791; 300050411; 300050413; 300072093; 300072094.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA.; ArjoHuntleigh AB.

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
    2054
  • Date
    2016-10-03
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    As part of efforts to ensure customer satisfaction and product quality and performance, ArjoHuntleigh has decided to replace manual control for the Maxi Move floor lifts affected by this problem. This is not expected to affect the safety of the device, but its durability. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link . #### UPDATED ON 09/4/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Reason
    Premature wear of manual control. internal tests and research activities that conductive ink, which is necessary for activation of manual control function, did not meet the predetermined durability requirements.
  • Action
    Field Action Code TAN 07-2016 triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA. Company will make field correction as directed in the Letter to customers.

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    ANVSANVISA