13 September 2018: This notice is superseded. Please see the updated statement.
The original decision to suspend the PB980 ventilator from the Australian Register of Therapeutic Goods (ARTG) has been revoked following a review of the Therapeutic Goods Administration (TGA)'s decision.
However, the review has led to a new decision to suspend the PB980 ventilator from the ARTG. The suspension is for a period of six months commencing on 5 February 2018.
The TGA remains concerned that the use of these ventilators has a potential risk of death, serious injury or serious illness. Issues that formed the basis for this new suspension were as follows:
- the current presentation and labelling of the scalar waveform functions of the PB980 ventilator can convey markedly inaccurate values for flow and tidal volume. These values may be different to the ones displayed in the patient data banner;
- the potential sequelae of relying on those inaccurate flow and tidal volume values as opposed to the values displayed in the patient data banner; and
- the Graphic User Interface (GUI) is unreliable, because of instances of the screen going blank and the GUI becoming unresponsive.
Medtronic is working with the TGA to resolve the above issues with the PB980 ventilator during the period of the suspension.
Information for consumers
PB980 ventilators are used only in intensive care units and other high-level care wards within hospitals.
If you or someone you provide care for is hospitalised and needs mechanical ventilation, please be aware that the health professionals who work in these areas are highly trained and have protocols to deal with the potential issues that may affect these devices where they are being used in the absence of alternatives.
If you have any questions or concerns about this issue, speak to the hospital staff.
Information for health professionals
The suspension means Medtronic may not supply new PB980 ventilators in Australia until the issues that gave rise to the suspension have been resolved. However, the suspension does not restrict use of PB980 ventilators already in use in Australia.
The Vt scalar waveform can display tidal volume values that differ markedly from the measured tidal volume. In testing by the TGA, measurements of tidal volume made using the Vt scalar waveform reported as much as double the tidal volume that was actually delivered to the mouthpiece, when using a paediatric breathing circuit.
The TGA considers that the issues involving the Graphic User Interface of the PB980 ventilator are an unacceptable risk to all patients because they include loss of monitoring of the patient's ventilation and unresponsiveness to attempted adjustments of ventilation.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).