Events

Alerte De Sécurité sur HAMILTON MEDICAL AG PULMONARY VENTILATOR - HAMILTON-G5, ANVISA Registry # 10338760025

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 HAMILTON MEDICAL AG.

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
    1379
  • Date
    2014-04-24
  • 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
    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.
  • Cause
    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).

Device

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

Manufacturer

HAMILTON MEDICAL AG