FOI release
Investigation adequacy and regulatory framework gap – CPAP incident (WM090TD SN 26739107)
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2026/00436
Received 21 April 2026
Published 3 June 2026
Request
I am writing to formally escalate concerns regarding the adequacy of the investigation into my reported CPAP-related incident involving: Löwenstein Prisma SMART Max (WM090TD) Serial number: 26739107 This escalation is made in light of MHRA’s internal review outcome (IR2026/00392), which raises significant concerns regarding the framework applied to my case. 1. Regulatory position confirmed by MHRA The internal review confirms that: “MHRA does not hold any current internal guidance, SOPs, templates, or decision-support material addressing how investigation boundaries should be defined in cases involving multiple components within a medical-device therapy pathway.” My case is precisely such a scenario, involving a therapy pathway comprising: * the primary device; * tubing and inlet filters; * a patient interface (mask) supplied by another manufacturer. 2. Concern regarding investigation boundary Given the absence of a defined framework, I am concerned that: * there was no consistent or standardised method for determining which components of the therapy pathway should be included within the investigation; * key components (including the patient interface and associated pathway elements) may not have been fully assessed; * the investigation may have relied on a narrowed scope without a clearly defined methodological basis. 3. Evidence handling and verification In addition, concerns arise regarding: * whether the full breathing pathway (device, tubing, filters, and mask) was preserved and assessed as a single system; * whether chain-of-custody and handling of returned components were sufficiently documented and verified; * the extent to which MHRA independently verified the manufacturer’s conclusions in the absence of a defined mixed-pathway investigation framework. 4. Clinical context This matter is not purely theoretical. Following the incident, I have experienced ongoing symptoms and subsequent medical findings, and it is therefore essential that any investigation into potential exposure pathways is robust, complete, and evidence-based. 5. Request for clarification I would be grateful if MHRA could provide a substantive response addressing the following: 1. What methodological basis was used to define the investigation boundary in my case? 2. Whether MHRA requires or verifies an assessment of the full therapy pathway, including patient-interface components; 3. How MHRA assured itself that the manufacturer’s investigation and conclusions were sufficient, given the absence of a defined framework for mixed-component systems; 4. Whether MHRA considers that the absence of internal guidance in this area presents a regulatory gap, and if so, what steps are being taken to address it. 6. Request for handling Please treat this as a formal escalation. I request: * confirmation of receipt; * identification of the named officer responsible for responding; * a substantive response addressing the points above. This request is made in order to understand the basis on which safety conclusions were reached, and to ensure that all relevant components of the therapy pathway have been appropriately considered.
Response
See attached
Documents
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