Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par MAQUET DO BRASIL EQUIPAMENTOS MEDICOS LTDA..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2320
  • Date
    2017-06-26
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA