Progress update

Philips Respironics field action

October 24, 2022

Extensive patient, clinician and regulator engagement

  • Driving patient engagement and registrations with new dedicated registration system and infrastructure
    • Patient outreach through mailing, call center, websites and direct contact with interest groups
    • Comprehensive DME outreach
    • Met the requirements in FDA's 518(a) order and continue to report progress
  • Engagement with regulators to optimize the recall efforts, and agree priority replacement
  • Sharing progress on testing program to ensure patients and physicians fully informed

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Around 90% of the recall program units produced and shipped by end 2022

The task at hand

  • Around 5.5M devices expected to be repaired or replaced
  • Equivalent to over 5x previous annual production volume
  • >1 thousand new product configurations released globally
  • Partnering with DME's for patient delivery

Progress to date

  • Quadrupled production capacity compared to pre-recall
  • >1,000 people cross functional team engaged
  • ~4M repair and replace units produced to date
  • Dependency on supply of materials and global logistics capacity

Production capacity - DreamStation

(compared to pre-recall)

2x 3x 4x

Q3 2021

Q3 2022

Q4 2022E

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Testing and literature review

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Extensive test and research program continues and shows insightful results to date

  • Hundreds of tests with long throughput time, working with certified testing labs and numerous external experts
  • Results to date for DreamStation1 devices
    • Very low prevalence of significant visible foam degradation in the over 63k devices inspected
    • Ozone cleaning materially exacerbates foam degradation
    • Volatile organic compounds (VOC) emissions within ISO limits (devices not exposed to Ozone)
    • Foam degradation does not contribute to appreciable elevated levels of respirable particles; within ISO limits
    • Even when significant visible particulates are formed, likely to accumulate and stick inside the device
  • Biocompatibility testing and assessment of PE-PUR foam is still on-going to fully assess potential patient risk
  • More information on the latest testing results can be found here:https://www.philips.com/a-w/about/investor-relations/recall-sleep-and-respiratory/testing

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Royal Philips NV published this content on 24 October 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 October 2022 05:09:03 UTC.