The Therapeutic Goods Administration (TGA), Australia has issued a medical device safety alert concerning B20, B30 & B40 Patient Monitors, manufactured by GE Healthcare.

The serial numbers of the affected products are identified as follows:-

• B20 - SGF11030001WA to SGF13176741WA (software version 1)
• B30 - SF309380033WA to SF313177120WA (software version 2)
• B40 - SG211210001WA to SG213172146WA (software version 1)
• B40 - SJF13010005WA to SJF13180144WA (software version 2)

The B20, B30 and B40 Patient monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used.

The additional 0.5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values. The ST-elevation measurement can be under-estimated in this situation and treatment of the patient can be delayed.

The manufacturer is providing users with work around instructions to follow until a software correction is available.

For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01027-1

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

Posted on 4 October 2013