Medical device manufacturer, Hamilton Medical, has issued a medical device safety alert concerning its HAMILTON-H900 [Part Number: 950001, 950004; All device with software version 1.10c incorporated].
According to the manufacturer, the analysis of several customer complaints has identified an issue relating to a delayed low water level alarm when starting the humidifier device with an empty chamber. This alarm delay occurs only in the HAMILTON-H900 software version HPC 1.10c. This issue pertaining to a delayed low water level alarm when starting the humidifier device with an empty chamber, has been corrected in the HAMILTON-H900 software version 1.10d.
The assessment for the delayed low water level alarm when starting the humidifier device with an empty chamber has been evaluated with a probability of occurrence of harm as occasional and the severity in the worst case could lead to a critical event.
In most cases, when the HAMILTON-H900 device has been prepared in accordance to the HAMILTON-H900 Operator's Manual 624431, once water is filled into the chamber, either manually or via auto feed, or the chamber has been removed and reinserted into the device, the alarm is acknowledged and reset. From this point on, the alarm functions correctly and the HAMILTON-H900 alarms when there is not enough water in the chamber.
However, in certain situations where the water source for the water auto feed is not properly installed or released, medical staff are unaware that there is no water in the chamber.
Device operators should take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 December 2020