Freedom of Information request on the number of patient safety incidents relating to in home ventilators produced by all manufacturers and provided in England (FOI 22/485)
Published 1 June 2022
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FOI 22/485
21st March
Dear
Thank you for your information request, dated 21/02/22, where you asked for information regarding the number of patient safety incidents relating to in home ventilators produced by all manufacturers and provided in England.
I can confirm that during 2019 there were 149 incidents involving ventilators. In 2021 this number was 280.
- Did any of the incidents relate to the patient’s device not working efficiently resulting in an exacerbation of their condition?
In 2019 there were 7 reports of patients experiencing unexpected deterioration as a result of an incident involving ventilation devices, in 2021 this number was 5. The data does not explicitly show if this deterioration was a result of the device not functioning correctly. Due to the nature of these devices it is possible that the device was functioning correctly however the patient’s health may have deteriorated for a number of other reasons.
With regards to your requests:
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How many of these incidents were reported as occurring in the patient’s home?
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Did any of the incidents in the patient’s home relate to the need of regular servicing of equipment? If so, are you able to provide some detail on what the reporter documented regarding the incident?
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Did any of the incidents relate to the patient’s device not working efficiently resulting in an exacerbation of their condition?
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Did any of the incidents suggest difficulties getting faulty ventilators repaired?
This is not the sort of information that is regularly captured by the yellow card system. This system captures device identifying information and device faults so that the information can be relayed to manufacturers who are required to carry out the investigation and report their findings to the MHRA. The condition and location of the devices is not requested directly by the MHRA therefore, I can confirm that we do not hold the information that you have requested.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
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