Ventilator manufacturer advised by senior coroner to take action to prevent future deaths

Posted: 11/10/2021

The Report To Prevent Future Deaths was issued by Kevin McLoughlin, senior coroner for the coroner area of West Yorkshire (East) following the inquest into the death of Mary Land, a patient who’s ventilator became detached at the connection point to the mask prior to her death. During the course of the inquest, the evidence revealed concerns that a risk of future deaths would occur unless action is taken.

Mary Land, aged 76, died on 5 February 2021 from respiratory failure after the tubes connecting her BIPAP ventilator became detached from her facemask. She was a patient on an acute respiratory care unit ‘surge’ ward at Pinderfields Hospital, Wakefield. 

Ms Land had a background of co-morbidities including atrial fibrillation and ischaemic heart disease. She was being treated for Covid-19 pneumonia when she was found in an unresponsive state, with the tube connecting her facemask to the ventilator having become detached. It was not possible to conclude at the inquest that this malfunction caused or contributed to Ms Land’s death but the coroner considered that there was a potential this could happen in other cases unless a design solution is found.

The device was a Philips Respironics AF 541 mask, which connects to the tubing, linking it to the BIPAP ventilator by means of a ‘push on’ connection. During the inquest, evidence was given to the effect that this connection had come undone on other occasions, suggesting a possible design defect. It appeared that there is a risk of the connection working loose or being inadvertently pulled apart. 

The senior coroner has recommended to Philips that it considers installing a more robust docking mechanism and requested a response from the company by 22 November 2021 setting out details of action taken or proposed to be taken.

Elise Bevan, partner in the clinical negligence and product liability team at Penningtons Manches Cooper commented: “We are sad to read about the death of Ms Land and concerned that this may have been due to a malfunction of the ventilator device that was being used to keep her alive. 

“We note that the senior coroner has issued a Regulation 28 Report To Prevent Future Deaths to the manufacturer, Philips. The company urgently recalled a number of its CPAP machines in June 2021 due to a potential safety issue with concerns that sound-reducing foam used in the devices may degrade into particles that may be ingested or inhaled by the user. 

“The problem identified in Mary Land’s case is potentially more serious and we anticipate that Philips will consider issuing a Field Safety Notice. We believe that there is the potential for future litigation to arise out of the affected devices but will await a statement from Philips regarding timescales and arrangements for any recall or workaround to fix existing devices.”

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