Medical device manufacturer, Hamilton Medical AG, has issued a medical device safety alert concerning its IntelliCuff Standalone. The model number involved is PN 951001 and the affected serial numbers are from 1000 to 2090.
The manufacturer's analysis of a customer complaint has identified an issue relating to the performance of the motor in the IntelliCuff Standalone device. During use, the motor may cease to function. The alarm sounds and the red LEDs blink in all segments. The IntelliCuff Standalone must be switched off to silence the alarm. The number of failures is unacceptably high causing nuisance alarms and customer complaints.
According to the manufacturer's assessment, there is no risk for the patient or user related to this failure.
Product recall and replacement is on-going.
The manufacturer will provide the necessary hardware improvements for IntelliCuff Standalone devices.
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 12 June 2017