Welcome to the MDI website. Content and updating of information is ongoing on our website, therefore if you cannot find what you are looking for please contact us.

Safety notice for specific breathing devices

September 22nd, 2021

We wish to let you know that Philips has issued a Field Safety Notice for specific breathing devices.

The Field Safety Notice informs customers and users of the devices of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken. Additionally, the notification provides details of Philips’s repair and replacement programme to correct this issue as efficiently and thoroughly as possible.

Philips has outlined the immediate actions to be taken by users of the devices:

For patients on affected BiLevel PAP and CPAP devices:

  • Please contact your physician or care provider before making any changes to your prescribed therapy.
  • While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment.
  • Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.

For patients on affected ventilator devices:

  • For patients on affected life-sustaining mechanical ventilator devices, do not discontinue or alter prescribed therapy without consulting with physicians, as well as instructions for modified continued use.

You can find out further information, including the list of devices affected, on this link https://www.philips.ie/healthcare/e/sleep/communications/src-update#section_2.

Please contact your MDI Family Support Worker if you’d like to talk to them about it.

Share Now:

Categories: Information

1. Muscular Dystrophies

  • Becker muscular dystrophy
  • Duchenne muscular dystrophy
  • Manifesting carrier of Duchenne
  • Congenital muscular dystrophy - General
  • • MDC1A (merosin-deficient congenital muscular dystrophy)
  • • Rigid spine syndrome (RSS)
  • • Ullrich congenital muscular dystrophies
  • • Bethlem myopathy
  • Emery-Dreifuss muscular dystrophy

2. Myotonic Disorders

  • Congenital Myotonic Dystrophy
  • Myotonia
  • Myotonic Dystrophy

3. Congenital Myopathies

  • Central Core Myopathy
  • Minicore (Multicore) myopathy
  • Myotubular or Centronuclear myopathy
  • Nemaline myopathy

4. Mitochondrial Myopathies

  • Mitochondrial Myopathies

5. Metabolic Disorders

  • Metabolic disorders (general)
  • McArdle’s Disease
  • Pompe’s Disease

6. Periodic Paralyses

  • Periodic Paralyses

7. Autoimmune Myositides

  • Polymyositis, Dermatomyositis and Sarcoid myopathy
  • Juvenile dermatomyositis
  • Inclusion body myositis

8. Spinal Muscular Atrophies

  • Severe (Type I)
  • Intermediate (Type II)
  • Mild (Type III)
  • Adult spinal muscular atrophy

9. Hereditary Motor and Sensory Neuropathies

  • (Also known as Charcot-Marie-Tooth or Peroneal muscular atrophy)

10. Disorders of the Neuromuscular Junction

  • Congenital myasthenic syndromes
  • Myasthenia Gravis

11. Friedreich’s Ataxia

  • Facioscapulohumeral muscular dystrophy
  • Limb-girdle types of muscular dystrophy (LGMD) - General
  • • LGMD 1B (also known as Laminopathy)
  • • LGMD 1C (also known as Caveolinopathy)
  • • LGMD 2A (also known as Calpainopathy)
  • • LGMD 2B (also known as Dysferlinopathy)
  • • LGMD 2I
  • Ocular myopathies including ocularopharangeal muscular dystrophy

12. Other (Please Specify)

13. Unspecified