The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning defibrillation electrodes for children manufactured by Leonhard Lang. The defibrillation electrodes are for use with defibrillators manufactured by GE Healthcare. The affected product codes are 2059144-001 and 2059144-005 (DF69, 50461) and the affected lot numbers are 21003-0770, 21113-0777 and 21220-0771.
Following an internal investigation triggered by reports in the field, the manufacturer identified that during the use of these defibrillation electrodes, a possibility for arcing and a resulting malfunction exists. This could lead to delay in therapy or no therapy at all. The inability to defibrillate or a delay in doing so can lead to the death or severe injury of the patient.
According to the manufacturer, this potential malfunction can occur with these electrodes after a duration of storage of about 2 years or more.
The manufacturer advises customers to quarantine the affected lot numbers and return them for replacement.
For details, please refer to the following link:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2014-RN-01266-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 December 2014