Invitation to issue a sanitary alert for falls in ventilators that affect patients with covid-19

For the treatment of covid-19 virus-induced symptoms, the state medical centers have been found to have medical devices that assist patients in their respiration. Among the unavoidable for the operation of the Intensive Care Units (UCI), are located the fans or artificial respirators, produced that the principles of the pandemic escaped in the country.

El pasado merercoles, the National Institute of Vigilance of Medicines and Foods (Invima) is issuing an alert for a referral of ventilators that could bring problems to patients who are being intubated by these devices.

Treat the fans to Hamilton H900, the brands are located in commercials in Colombia with the title of Electronics and Control Emco SA. Dicha company is located registered in Medellín, with operations in the department of Antioquia. Following the page of the trade, dichos fans are part of the catalog.

According to the authority, the product is used specifically in “Obstruction of the respiratory tract, respiratory failure, respiratory failure and all the traumas, injuries or injuries that can interfere with respiration. It is used in intensive care units, special rooms, emergency rooms and intra-hospital transport ”, before the scintillation was presented, it could be concluded that it coincided with the needs of the patients that coed-19 pads.

The problems in this fan reference are presented in all the devices with version 1.10c software incorporated. According to the manufacturer’s card, it is treated as a case, manifested by various customers, related to “A return of the water level alarm when the humidifier is initiated with a vacuum chamber”.

For the functioning of the artifact, the constant water watering period is vital. In the event that it accepts or detects the summit, the device notifies you by means of an alarm. With the defect, the devices emit an alert late or no harian. In this case, the UCI staff will not be able to take any action that is not taken with the liquidity.

According to the company Hamilton Medical, the probability of foreclosure of the day is second. Without embarrassment, the communication recalls that pregnancy, in the case of the cases, “You can lead a critical event”.

In the version of Invima, it is explained that the problem arises “Deliver on the possible presentation of events or incidents that adversely affect the patient”.

The authority, which has been alerted to the problem by the importer in Colombia, advises the media on the health centers that it uses and can communicate with the distributor or dealer to specify which actions to follow. Según Hamilton, due to the correspondence of the delicada that verifies the software of the respirator 1.10dy, is the verification of the alarm and the suministro de agua funcionen correctamente.

In view of this action plan, the Colombian authorities require importers and distributors to initiate traceability measures and start implementing the measures taken by the manufacturer.

Además, the institution helps that, if it encounters another problem of the reference, it communicates with the competent competent to take medias in the matter.

“Invima solicits that from the Tecnovigilancia’s institutional programs the active search is carried out for the detection of incidents or adverse incidents involving the referenced medical device and notifying Invima”, finalization, giving the notification of the electronic mail [email protected].

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