Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Philips Medical Systems Ltda.; Philips Medical Systems (Cleveland), Inc..

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
    1546
  • Date
    2015-03-30
  • 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
    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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    ANVSANVISA