Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning all models of its Puritan Bennett 980 (PB980) ventilator for the following two issues:
- Graphical user interface (GUI) unresponsive to touch
- In this situation, the ventilator continues to operate at existing settings, all real-time waveforms and pressure/volume measurements, as well as alarm functions and the bezel keys (hard keys below the touch screen), remain active. However, in this situation, users are unable to change ventilator settings or the configuration of the GUI display. Should this occur, the clinical team should transfer the patient to another ventilator.
- The frequency of occurrence based on reported complaints is 1.3%, corresponding to an annual rate of 0.7%.
- Loss of primary ventilation under certain circumstances
- The manufacturer has received reports of the PB980 ventilator losing primary ventilation capabilities, in which case the Backup Ventilation (BUV) design feature is activated.
- When BUV is initiated, high urgency audio and visual alarms are annunciated immediately and cannot be silenced. The clinical team should transfer the patient to another ventilator.
- In some cases, the ventilator subsequently progressed to a ventilator inoperative condition, in which case, by design, the ventilator opens all valves to atmospheric pressure and room air, and ventilation ceases. High urgency audio and visual alarms are annunciated. The clinical team should transfer the patient to another ventilator.
- The manufacturer's investigation revealed that background diagnostic software responsible for monitoring ventilator system function inappropriately determines a hardware problem exists. The ventilator then moves to BUV and occasionally into ventilator inoperative. As stated above, when this occurs the clinical team should transfer the patient to another ventilator.
- The frequency of occurrence based on reported complaints is 1.6% corresponding to an annual rate of 0.9%. Approximately 50% of these events occurred at ventilator power-on/start-up.
Affected users may continue to use their PB980 ventilators. They are advised to ensure patients on PB980 ventilators are appropriately monitored by medical personnel and suitable monitoring devices as described in the Operator's Manual. The manufacturer will develop and implement corrections for these issues.
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 25 January 2016