Australia: St John sues supplier over defibrillators 'not suitable' in emergency situations - - PressFrom - Australia
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Australia St John sues supplier over defibrillators 'not suitable' in emergency situations

02:07  11 october  2019
02:07  11 october  2019 Source:   watoday.com.au

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St John Ambulance WA is suing an Australian medical supplier over claims it was sold nearly $5 million worth of defibrillators not suitable in an emergency environment.

In a writ lodged in the Supreme Court of Western Australia on Wednesday, St John claimed Laerdal had been "deceptive" when it sold the emergency service 264 HeartStart MRx Philips defibrillators, valued at $17,670 each, between 2012 and 2017.

St John claims the devices – which have since been subject to an urgent recall in the United States – did not withstand the rigours of the ambulance environment and were not easy or reliable to use.

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"To the knowledge of [Laerdal], a paramount feature of the MRx Philips devices required by [St John] was their operational reliability and ease of use in circumstances of patients of [St John] requiring emergency medical treatment for life threatening heart conditions," the writ read.

"As a failure to operate efficiently or difficulty of use might have, as a result, the death of a patient [sic], who urgently required defibrillation, cardioversion, pacing or monitoring.

"In or about 2012, [Laerdal] represented to [St John] that it was common knowledge that time to defibrillation was critical and that for each minute defibrillation was delayed a 10 per cent reduction in survival was expected."

St John claimed the devices, as a result of the 2017 recall in the United States, "could not be relied upon to deliver lifesaving defibrillation therapy".

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According to the U.S Food and Drug Administration, the reason for the recall was due to "electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy".

The alert claimed the device may also unexpectedly stop pacing and a delay in delivering therapy could result in serious patient injury such as organ damage, brain injury or death.

An Australian recall of the device, issued by the Therapeutic Goods Administration in May this year, said there had been one reported death "potentially involving an AC Power Module failure in a HeartStart MRx that did not have a battery installed".

A St John Ambulance WA spokesman said the agency was working to replace the defibrillators.

“This is a $6-7 million replacement program,” he said.

“Our contingency plan of back up defibrillators is being employed so that patient care is not compromised.

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“St John is seeking unliquidated damages that will be determined by the court.

“We are unable to provide further comment as the matter is before the courts.”

A Laerdal spokesman on Thursday was unaware St John had commenced legal proceedings against the company.

“St John WA have used the Philips MRx defibrillator extensively for over seven years,” he said.

“In this period of time the MRx has been used to save hundreds of lives and out of hospital cardiac arrest survival in Western Australia has improved dramatically.

“We believe there is no factual basis to this supposed writ and will vigorously defend it.”

Philips advised in May 2017 that the HeartStart MRx would no longer be supplied.

Although removed from the Australian Register of Therapeutic Goods on 19 July 2017, according to the Theraputic Goods Administration, the HeartStart MRx continues to be used and fully supported in hospitals, private clinics and ambulance fleets across Australia to save lives.

Philips has entered into a Memorandum of Understanding with the TGA in which it has agreed to notify any actual or anticipated shortages of accessories, repair parts and consumables of the HeartStart MRx in Australia until December 31, 2022, and to remedy them as soon as reasonably practicable.

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