Thousands of devices that monitor the vital signs of patients in Australian hospitals may be at risk of failing to sound the alarm when lifesaving care is needed, authorities have warned.
Australia's medical devices watchdog, the Therapeutic Goods Administration, has suspended the sale of Philips IntelliVue MX40 wearable patient monitors, after escalating reports of speaker failure.
A TGA investigation revealed it was "possible the device would not sound an alarm in critical situations," and although the likelihood of this was low it was considered to be "unacceptable under the circumstances," a TGA spokeswoman said.
The device monitors, records and generates alarms for the patient's heart rate, oxygen saturation and other physiological parameters.
It relays the information to a central station that is monitored by clinical staff but if a patient is being transported from one hospital to another, or moved from ward to ward, it is not connected to the station and this is of particular concern if the speaker fails.
About 2200 of these devices have been supplied by Philips to Australian health services but the TGA did not say which hospitals or ambulance services use them.
Ambulance Victoria does not use the devices.
The TGA has not called for health services to stop using the devices, and has instead advised medical staff to check they are working properly.
"Due to the critical need for patient monitors in hospitals and the impracticality of replacing existing devices, the TGA is not recommending that units that have not demonstrated this problem be taken off service while the corrective action takes place," the regulator advised.
"However, we recommend hospital staff carry out routine testing and maintenance on these devices."
Kevin Barrow, managing director of Philips Australia and New Zealand, said the issue related to a failure of the device's speaker and did not affect any other functions of the device.
Between April 2014 and 2017 there were 65 reportable complaints received about the speakers, Mr Barrow said in an emailed statement.
"Philips regards this matter with the utmost seriousness, and we are dedicated to providing safe and effective medical devices to our customers and their patients who rely on them," he said.
"Philips is in discussion and working closely with the TGA to clarify and resolve this matter."
Mr Barrow said Philips had "addressed" the speaker issue and improved the design of the device, which has "resulted in very low or non-existent speaker failure reports for newer devices."
The TGA suspension will remain in place until the issue is corrected in new and existing devices.
The patient monitors are used in some Victorian hospitals, a spokesman from the Department of Health and Human Services said.
"Safer Care Victoria supports advice from the TGA that this product can continue to be used in hospitals with careful monitoring," he said.
"We are liaising with the manufacturer and Health Purchasing Victoria and providing advice to public and private hospitals across Victoria."
