The Medicines and Healthcare products Regulatory Agency (MHRA) recently initiated a medical device alert as a result of Philips Respironics’ faulty software that could lead to a sporadic shutdown of the medical device.
The Respironics V60 ventilator’s are used in hospitals to assist in patient ventilation. Recently the medical manufacturer issued a Field Safety Notice (FSN) to notify users of the risk.
Field Safety Notice
The FSN published on 8th February 2017 notifies customers who on record have previously purchased the Philips V60 Ventilator. Respironics voluntarily recalled all V60 Ventilators that have version 2.20 software installed. There may be a grey area for some customers who updated their software from version 2.10 to version 2.20, but the manufacturer notes that if the software update was made to the V60 Ventilator between 17th April 2016 and 4th January 2017, then the recall will apply.
Correction method
To resolve the issue the manufacturer is to revert the Philips V60 Ventilators from version 2.20 back to version 2.10, in accordance with national law.
The recall signed by Donald Sherratt, Head of Quality and Regulatory at Hospital Respiratory Care, notes that it’s easy to see which version of the software is installed. There’s also a strict warning that serious injury or death could result if users don’t respond to device alarms triggered by version 2.20 the software.
Issue with the device
If the V60 Ventilator has version 2.20 of the software installed, the manufacturer noted that it may falsely detect that the blower motor has stalled. If this happens, the software may cause the ventilator to shut down (Vent Inop) and display Error Code 100E. As a result of this, ventilator support may stop.
An audible high-priority alarm should sound continuously for at least 2 minutes when the V60 shuts down. If the V60 is connected to a mains supply, the alarm may continue to sound until someone intervenes.
The error code 100E should only appear in version 2.20 of the software.