Events

Safety Alert for LEGENDAIR Pulmonary Ventilator. Registration ANVISA: 80136710174 - Model 4095700 - Serial Numbers affected in annex.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MALLINCKRODT DO BRASIL 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
    1127
  • Date
    2012-04-23
  • 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
    According to the manufacturer, there have been 13 recent cases reported from Linde Healthcare of Sweden related to engine control. Complaints reported were for "non-operation of DC power supply" or "did not power on when operated by internal battery"; "interrupted / damaged contact"; "does not turn on"; "the turbine does not start" and "the machine suddenly shuts off without warning". After investigation, such complaints were associated with failures in the capacitor C53. This may cause the fan to not start or operate on the internal battery. In this cases, it only works with the external battery or AC power cable. #### UPDATE - 08/24/2012 - The company informs that the field action has been extended to replace the motor control board, which contains the capacitor C53 #### SEE ANNEX! http: //portal.anvisa.gov.br/wps/wcm/connect/0ea853804c840cce9c8edd93d95c4045/Carta+ao+Client+Updated+1127.pdf? MOD = AJPERES ## ## Update (05/04/2013): Up to now, the company has corrected 18 units, out of a total of 147 affected equipment.
  • Reason
    Potential failure of a component identified as capacitor c53, may cause the fan to not start or operate with the internal battery, needing to be connected to external battery or ac power cord.
  • Action
    All customers have been advised that the capacitor should be replaced. To this end, the company forwarded a Letter to Customers with Addendum to the Manuals and prepared a Field Action Plan. Health care workers and / or caregivers should redouble their attention in cases where the equipment is in exclusive use of the internal battery. The user's manual contains the following INTERNAL BATTERY OPERATION alert: "Due to its limited range, the fan should only be used with the internal battery occasionally. An external power supply must be available when using the device only with the internal battery The passage to the internal battery is systematically accompanied by an alarm ". SEE CUSTOMER LETTER UPDATED! Http: //portal.anvisa.gov.br/wps/wcm/connect/0ea853804c840cce9c8edd93d95c4045/Carta+ao+Client+Updated+1127.pdf? MOD = AJPERES

Device

LEGENDAIR Pulmonary Ventilator. Registration ANVISA: 80136710174 - Model 4095700 - Serial Numbers...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.