Medical device manufacturer, Dragerwerk AG & Co. KGaA, has issued a medical device safety alert concerning its products, WaterLock 2 and WaterLock 2 Infinity ID [Part Number: A) 6872130, B) 6872020. Lot Code: A) ASLH-F004, ASLH-F005; B) ASLH-F001].
The manufacturer has become aware that, during assembly by their supplier, the diaphragms in a number of the affected product water traps were fitted the wrong way around.
According to the manufacturer, this can shorten the lifespan of the water trap and thus result in a failure of the measurement - possibly after just a few hours of operation, depending on the humidity content of the breathing gas. The anaesthetic gas monitoring will detect the failure of the measurement and will alert users by giving an appropriate technical alarm.
In this case the water trap will need to be replaced. The functionality will not be affected prior to failure of the measurement.
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Oct 2018