The Health Sciences Authority (HSA), Singapore posted a medical device safety alert concerning Monitor/ Defibrillator DEFIGARD Touch7 [All devices with software version up to "SOFT 5" are affected].
The DEFIGARD Touch7 can be configured in 3 different start modes (Monitoring, AED or manual defibrillator). The Field Safety Notice concerns devices configured in start mode "manual defibrillator'.
If the user starts the device in this configuration, and switches directly from the manual defibrillation to the Synchronized Defibrillation mode, without ECG patient cable being plugged, then the device will be unable to trigger the synchronized defibrillation shock. This can be seen on the screen of the device, no trigger pulses are available. If the patient cable is connected, according to the user manual, this failure does not occur.
According to the manufacturer, it may be unable to perform synchronized defibrillation therapy. The manual defibrillation mode at start is a specific medical emergency service setting. It is used when rescuer wants to mainly use the device as manual defibrillator. The synchronized defibrillation is not an emergency procedure, and it is recommended to perform it with ECG Patient cable.
While waiting for the update of the DEFIGARD Touch 7, affected users are advised to continue to use it without restriction. If user startup configuration with manual defibrillation mode, user has to select another startup mode, until the update to software "Soft 6", or use a patient cable for the synchronized defibrillation therapy, as described in the user manual.
For details, please visit the following HSA website:
http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2017/November/HSA%206004101-056-17-06_36%20FSN_Redacted.pdf
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 January 2018