Events

Alerte De Sécurité sur Uninterruptible Power Supply (UPS) - Used in Philips equipment; Brand Philips; registration of the affected products: 10216710106; 10216710170; 10216710232; 10216710134; 10216710267; 10216710196; 10216710218; 10216710177; 10216710189; 10216710277; 10216710168; 10216710193; 10216710197; 10216710191; 10216710209.

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 Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

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
    1546
  • Date
    2015-03-30
  • 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
    This may be due to non-preventive maintenance or periodic battery replacement. The risks involved in the failure of the device are: chemical or thermal burns and irritation in the eyes, nose or throat. #### UPDATED 7/18/2017, the company sent a field action completion report, foreseen.
  • Cause
    Ups devices fail (uninterruptible power supply) resulting in battery acid leakage, overheating or smoke emission. all ups devices with lead acid batteries are susceptible to this problem.
  • Action
    According to the registration holder's instructions, the customer should analyze the contents of the folder and implement a UPS maintenance program as recommended by the manufacturer of his UPS. /// If you notice any unusual odor and / or heat, or see any liquid in the UPS area, do not touch the device or the surrounding liquid. Follow your institution's procedure for potentially hazardous materials. Inform all persons in the vicinity of this potentially dangerous situation, including but not limited to - patients, staff and maintenance personnel. Contact your service provider immediately.

Device

Uninterruptible Power Supply (UPS) - Used in Philips equipment; Brand Philips; registration of th...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc.
  • Société-mère du fabricant (2017)
    Philips
  • Source
    ANVSANVISA