The Ministry of Health withdraws an anesthesia machine for a technical malfunction threatening death

The Ministry of Health and Community Protection issued a decision to withdraw a device for mechanical anesthesia and breathing, due to a technical malfunction that might expose patients to death, in addition to withdrawing four products of a gel used for medical purposes that might lead to patients with infectious diseases.

In detail, the Ministry of Health and Community Protection has warned against the use of the Carestation 600 series anesthesia systems, produced by GE Healthcare, which are used as anesthetics and mechanical respirator support. The Ministry attributed the reason for the warning in its circulation to health facilities and caregivers to the possibility of incorrectly connected wires inside the device, which may cause mechanical ventilation to stop working, at which point the device will issue an audible and visual alarm.

The ministry indicated that the loss of mechanical ventilation will cause a decrease in the oxygen level in the patient's blood, which may lead to tissue and organ damage or death.

The Ministry requested that the mechanical ventilation should be replaced by manual ventilation or using another anesthesia device, when the alarm is heard during the use of the 620/650 / 650c, A1 models, and the representative of the manufacturer will contact their suppliers to inspect and correct the affected devices, with hospitals committing to conduct annual periodic maintenance of these Devices, to ensure that the wires are connected properly, knowing that this product is not registered with the Ministry of Medicines Administration.

In another circular, the ministry decided to withdraw four products of a gel used on the skin before applying the electrode to the patient, because it may be contaminated with bacteria (Burkholderia cepacia), and may lead to the risk of infection for patients using these products.

The ministry explained that these products are, skin preparation electrode gel: LemonPrep, PediaPrep, wave Prep and cardio Prep.

A gel used for medical purposes that threatens to infect patients with infectious diseases.