Events

Safety Alert for Ambu Resuscitation, Self-Inflating, Manual

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    372
  • Date
    2002-02-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The medical devices agency (mda / uk) issued a safety alert upon receipt of an incorrect reassembly report from the manual resuscitator, which rendered them ineffective in emergency situations. mda states that various components of these appliances have been incorrectly positioned, and valves have been reversed.
  • Action
    MDA recommends the following care: (1) The Manual Resuscitator should only be cleaned and reassembled by appropriately trained personnel following the manufacturer's instructions. (2) During cleaning, the resuscitator must be thoroughly checked (checked) for correct operation. (3) The Manual resuscitator should only be used by individuals who have received adequate training. MDA states that Medical Devices Controls Assurance Standards practice guidelines should be followed and these current / current standards are available on the Internet at http://www.casu.org.uk. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485. Comments: ECRI also wrote about this problem (testing reuse of manual resuscitators). Health Devices August 28, 1999 [8]: 323). Also, note that MDA says that Manual Resuscitators that are inadequate will not work, but also, according to ECRI's warning, can cause harm to patients when resuscitators are handled or reassembled improperly. As a result, ECRI suggests that these products be checked for proper operation prior to each use. Comments: This incident is based on information from the MDA vendor that may not be independently verified with respect to the accuracy or causal relationship with specific products or vendors.

Device

Ambu Resuscitation, Self-Inflating, Manual
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA