8 March 2018: This notice is superseded. Please see the updated statement.
Consumers and health professionals are advised that the TGA has suspended the Covidien/Medtronic PB980 Ventilator from the Australian Register of Therapeutic Goods (ARTG) for six months.
This action has been taken as the TGA is concerned that, until rectified, use of these ventilators raises a potential risk of death, serious injury or illness.
PB980 Ventilators provide respiratory support to patients in intensive care units or other high-level care wards within hospitals and during intra-hospital transport.
These ventilators have been the subject of several complaints relating to the screen going blank, graphical user interface (GUI) becoming unresponsive, unexpected shutdowns or restarts, false triggering, serial number mismatch and USB failures. Additionally, Medtronic has identified issues with accuracy when used with newborn infants (NeoMode).
Some of these issues had been progressively addressed in a series of software updates during 2015 and 2016. However, further incident reports were received subsequently and testing by TGA laboratories in 2017 found a range of serious issues persisted.
The TGA sought expert advice from the Advisory Committee on Medical Devices (ACMD) regarding the clinical risk of the accuracy of ventilation observed by the TGA's Laboratories, the clinical risk of the issues with the device's user interface, and the safety of the performance specifications published in the operator's manual.
Following its meeting on 24 August 2017, ACMD advised the TGA that:
- The issues with the user interface, including the loss of interactivity with control settings, which were observed by the TGA Laboratories and in Device Incident Reports, were an unacceptable risk to patients for a device intended to be used in a critical care environment.
- The discrepancies in ventilation accuracy observed by the TGA Laboratories were an unacceptable risk to paediatric patients.
- The tolerances for variation in ventilation therapy that are reported in the operator's manual were not suitable for paediatric patients.
In addition, the committee believed it would be difficult to set conditions under which the use of this device may be safe for paediatric patients, that is a patient weighing less than 35 kg.
The TGA has notified State and Territory health authorities, private hospitals and clinics of the decision to suspend the Device from the Register. TGA recommends that health professionals consider not using the device where suitable alternatives are available, noting that the sponsor has the opportunity to rectify the issues identified.
This is not a recall from service of existing devices. This is a notification about a decision to suspend the product which means that no new devices can be supplied by the sponsor for 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 TGA considers that the issues with the user interface of the devices are an unacceptable risk to all patients because they include loss of interactivity and loss of monitoring.
The TGA considers that the PB980 should not be used on paediatric patients, particularly those under 35 kg, until the issues that have been identified are rectified. For example, in paediatric mode if a tidal volume of 25 mL is programmed, the manufacturer's specification says it is acceptable for the PB980 ventilator to deliver between 12.5 and 37.5 mL, which represents a 50 per cent error in ventilation delivery.
If using a neonatal circuit for patients (i.e. in Neomode 2.0) with the optional proximal flow sensor accessory, the specifications are tighter. For example, if the PB980 ventilator is operating in Neomode 2.0 with a neonatal circuit and programmed to deliver a tidal volume of 5 mL, the manufacturer's specification says that it can deliver between 3.5 mL and 6.5 mL, which is a 30 per cent error in ventilation.
The waveforms can display measurements that differ from the top banner measurements. In testing by the TGA Laboratories, measurements of tidal volume made using the waveforms reported as much as double the tidal volume that was actually delivered to the mouthpiece, when using a paediatric breathing circuit.
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).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.