Events

Safety Alert for Trade name: Flowtron ACS900 System Technical Name: Member Compression System ANVISA Registration Number: 80259110105 Hazard Class: I Affected Model: Flowtron ACS900 System Affected Serial Numbers: All Serial Numbers / All Lots manufactured between 09/26 / 2014 and 12/20/2016, with software V1.099.

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..

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
    2320
  • Date
    2017-06-26
  • 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 device may remain in use until modernization is performed, provided that the patient's limbs are frequently monitored and the dressing checked to ensure they are properly fitted to the patient and that deflation of the clothing is occurring regularly. It is also recommended that the LCD display of the pump be checked regularly to ensure it shows that the suits are inflating and deflating correctly. In the limited number of complaints, the LCD display was blank.
  • Reason
    It has been identified that in some cases the bomb will constantly transmit pressure to the suit without triggering the alarm. arjohuntleigh investigated the symptom found and concluded that the consistent flow of pressure to the suit without deflation can lead to a potential risk of injury to patients. arjohuntleigh has received a limited number of complaints related to this specific state. although this is likely to be remote, arjohuntleigh takes this issue seriously and advises you on the following steps: modernizing the acs900 pump for reviewing v.2000 software to ensure more resilient flowtron systems. the device may remain in use until modernization is performed, provided that the patient's limbs are frequently monitored and the dressing checked to ensure they are properly fitted to the patient and that deflation of the clothing is occurring regularly. it is also recommended that the lcd display of the pump be checked regularly to ensure it shows that the suits are inflating and deflating correctly. in the limited number of complaints, the lcd display was blank.
  • Action
    Field Action Code FSN-SUZ-001-2017 triggered under the responsibility of the company MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA. Company will make correction in the field.

Device

Trade name: Flowtron ACS900 System Technical Name: Member Compression System ANVISA Registration ...

Manufacturer

MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA.
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA