Safety Alerts

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Dragerwerk AG & Co. KGaA Oxylog 3000 plus [Part No.: 570811 and 5704813] [HKMD No.: 160397].

According to the MHRA, the manufacturer has become aware of instances emergency and transport ventilator Oxylog 3000 plus devices stopped ventilation due to a discharged battery. This happened despite the fact they were connected to a mains supply after prior battery operation. No serious injuries to patients have been reported as a result of this issue.

According to the manufacturer, the root cause of the inability to switch to mains supply could be identified as a problem of the charging circuit which can occur in the following sequence of situations:

1. A prior battery issue indicated by the alarm “No int. battery charging” occurred during use on mains supply and
2. The internal battery is NOT removed and reinserted or replaced as recommended as remedy for this alarm message according to the Instructions For Use (IFU) and
3. The device is disconnected from mains supply (e.g., for patient transport) and
4. The device is reconnected to mains supply

Only if all the conditions listed above are fulfilled and after the aforementioned alarms were given, ventilation could stop as soon as the battery charge was depleted. Ventilation can be maintained using the manual resuscitator which needs to be ready according to the IFU.

For further information, please visit https://mhra-gov.filecamp.com/s/d/G0JOvjIdPLpt9tKu

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 24 May 2023