Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning the software update of its Capnostream 35 Portable Respiratory Monitor.
The manufacturer is releasing a software update V01.05.02.16 (also known as V1.5.2) for the Capnostream 35 portable respiratory monitor currently running software version V01.05.00.416 (also known as V1.5). The software is now available and can be accessed at http://medtronic.com/cap35software.
According to the manufacturer, the software is released in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm. There have been no incidents of patient or user injury related to this issue which may result in a delay in treatment while an alternate monitor is obtained.
The initial investigation from the manufacturer revealed that the cause for the errant message is potentially related to faulty cells within the device battery pack which trigger a software anomaly to incorrectly identify a battery temperature which exceeds the design limits.
In addition, the manufacturer has issued an addendum to the Capnostream 35 Portable Respiratory Operator's Manual which can be accessed from its website at: manuals.medtronic.com.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 17 November 2020