Safety Alert for HAMILTON MEDICAL AG PULMONARY VENTILATOR - HAMILTON-G5, ANVISA Registry # 10338760025

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

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
    1379
  • Date
    2014-04-24
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    The occurrence of the problem is extremely rare, due to the 50-millisecond time window in which both actions must occur: the detection by the instrument of a disconnection and the termination of an oxygen enrichment (O2) procedure in the gas mixture which follows for the patient. If the error is not detected by the operator after the patient's aspiration maneuver and PEEP is set to a lower value of 4 mbar, patient hypoxia may occur, putting your life at risk. Although it is very difficult to happen, in the occurrence of the error, the patient may be put at risk. However, the corrective action that deactivates the function of the automatic suctioning maneuver is very simple and quick to execute, as well as verifying that the deactivation has taken place. Immediate action required of fan users: as soon as the suctioning maneuver is completed, the user must make sure that ventilation continues. If ventilation is interrupted, one of the following options can be used to restore ventilation: 1- Press the "Manual Breathing" button on the front panel of the ventilator, 2- Toggle the Ventilation Mode or 3- Activate the standby mode ( "Standby") and return to the previously set Ventilation Mode.
  • Reason
    Investigations have shown that ventilation and alarms of the hamilton-g5 pulmonary ventilator can be accidentally suppressed following the activation of a suctioning maneuver by the operator under a series of very specific circumstances. the ventilation should then be manually reactivated. the main cause, a synchronization problem of two program tasks processed simultaneously can result in fatal hypoxia in the patient.
  • Action
    Field Correction (Deactivation of function that may cause the problem).

Manufacturer