FOI release
Foam materials, testing, vigilance & UDI records
Case reference FOI2025/01140
Received 27 October 2025
Published 4 December 2025
Request
This is a request under the Freedom of Information Act 2000. Context (for search only): Patient adverse incident relating to Löwenstein prisma SMART max CPAP WM090TD supplied in GB; MHRA handling references CEC 233182 and Yellow Card 2025/005/018/501/003. Scope and timeframe * Timeframe: 1 January 2024 – present. * Device: Löwenstein prisma SMART max WM090TD (all GB configurations; include any UDI/Basic-UDI identifiers recorded by MHRA). * Records held by MHRA in any form (emails, letters, file notes, database entries, attachments, meeting minutes, slide decks, spreadsheets). Information requested (editable/redacted copies welcome) 1. Foam material / design-change communications * Correspondence with the manufacturer/sponsor/UK representative about sound-abatement foam used in WM090TD, including material family (polyester-PU / polyether-PU), placement in the breathing gas pathway, and any design-change notification. * A one-page extract/screenshot showing the effective date and/or production identifiers (lot/serial/UDI-PI) MHRA recorded or was notified of for the foam configuration change. 1. ISO 18562 / biocompatibility evidence reviewed by MHRA * Any test reports, summaries, or review notes MHRA received/reviewed regarding ISO 18562-2/-3 particulates/VOCs for WM090TD (or the representative device the manufacturer relied on), and any MHRA internal assessment notes of those reports. * If full reports were requested but not received, please supply the request(s), follow-ups, and responses indicating non-receipt. 1. Intake evidence and investigation artefacts provided to MHRA * Any time-stamped intake photographs, chain-of-custody logs, sample handling logs, analytical method files (e.g., FTIR/SEM-EDX/GC-MS summaries) or test-lab accreditation details supplied to MHRA by the manufacturer/sponsor for this case. * If MHRA does not hold these artefacts, please provide the MHRA request(s) for them (if made) and any responses declining. 1. Risk management & PMS/vigilance * Any risk assessments or risk-benefit evaluations MHRA received/reviewed from the manufacturer relating to foam degradation/particle emission in WM090TD (ISO 14971 context). * Post-market surveillance records held by MHRA for WM090TD: signal detection notes, case aggregation, assessment memos, and any decision records for “reportable vs non-reportable” classification of this incident. 1. UDI/Basic-UDI and device master data * The UDI-DI and Basic UDI-DI entries MHRA holds for WM090TD in GB and the effective-date metadata for the configuration that reflects the foam change. A database screenshot/export is sufficient. 1. IFU/label review * Any MHRA notes, emails, or assessments regarding IFU/label content for WM090TD as it relates to disclosure of gas-path foam materials/risks and any outcomes (e.g., requests to the sponsor, compliance checks). 1. Regulator liaison * Any communications with other regulators (e.g., TGA, FDA) about WM090TD foam composition/design change and/or vigilance signals, including any MHRA internal notes summarising those exchanges. 1. Case outcome records * The closing note/minute (one page) for MHRA’s internal entry on this case indicating the rationale for accepting the manufacturer’s conclusion and any conditions/follow-up (e.g., request for full reports outstanding). If information is not held / held elsewhere * If any category above is not held by MHRA, please provide a one-line confirmation of “not held” and, under s16 FOIA, indicate the public authority/body (e.g., Approved Body/Notified Body) most likely to hold it, if known. Format & narrowing * Electronic copies are preferred (PDF/CSV/screenshots). * I consent to redaction of personal data and commercial specifics that are not necessary to show what was provided/recorded and when. * If any elements engage s43(2) or other exemptions, please provide partial disclosure of non-sensitive fields (e.g., dates, identifiers, document titles, decision summaries) and a schedule of documents describing what is withheld and why. Public interest This request concerns patient safety and post-market surveillance for a life-supporting respiratory device. Narrow extracts showing what MHRA requested/received, what was recorded about foam configuration/effective dates, and what assessment took place serve the public interest and enable coherent cross-jurisdictional safety management.
Response
See attached
Documents
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