This is an example of the report Neuridion generates after a PMS database search. All data shown is illustrative.
| Device Name | InfusoGuard 3000 Patient Monitor |
| Manufacturer | MedTechnik GmbH |
| Device Classification | Class IIb |
| EMDN Code | Z12030101 |
| Review Period | 2025-06-01 to 2026-05-01 |
| Report Date | 17 May 2026 |
| Document Reference | PMS-FSN-2026-A7C3E1D2 |
| Databases Searched | BfArM, FDA MAUDE, MHRA, Swissmedic |
| Search Date Range | 2025-06-01 to 2026-05-01 |
| Manufacturer Terms | medtechnikinfusoguard(derived from “MedTechnik GmbH”) |
| Device Terms | patientmonitor(derived from “InfusoGuard 3000 Patient Monitor”) |
| Assessment Criteria | Each notice was evaluated for device type, manufacturer, intended use, and applicable risk. |
| Title | Manufacturer | Date | Source | Rationale |
|---|---|---|---|---|
| FSCA: Battery overheating in patient monitoring system during extended use | Drägerwerk AG | 12 Mar 2026 | BfArM | Same device class (IIb) and intended use (patient monitoring). Battery subsystem overlap with InfusoGuard 3000. EMDN match at Z1203 group level. |
| Medical Device Alert: Software defect in vital signs display during SpO2 monitoring | Philips Healthcare | 28 Feb 2026 | MHRA | Equivalent device function (vital signs monitoring). SpO2 display error relevant to patient monitoring safety. Same intended clinical setting. |
| FSCA: Alarm volume reduction after firmware update in bedside monitoring systems | Nihon Kohden | 15 Jan 2026 | BfArM | Same device category (bedside patient monitor, Class IIb). Alarm system is a shared critical function. Firmware update mechanism may be architecturally similar. |
| Title | Manufacturer | Date | Source | Rationale |
|---|---|---|---|---|
| Adverse event report: Intermittent network connectivity loss in wireless patient telemetry | GE HealthCare | 15 Feb 2026 | FDA MAUDE | Different device class (IIa telemetry vs IIb monitor), but shared wireless protocol (IEEE 802.11). Network connectivity failure mode may apply if InfusoGuard 3000 uses wireless data transmission. PRRC review recommended. |
| FSCA: Incorrect ECG lead placement detection in multi-parameter monitors | Mindray Medical | 09 Nov 2025 | Swissmedic | Multi-parameter monitor with ECG capability. If InfusoGuard 3000 includes ECG functionality, the lead detection algorithm may share similar design patterns. Requires verification of InfusoGuard feature set. |
These items were reviewed and determined not relevant to the device profile. Listed for audit completeness. Showing first 3 of 42 for this sample.
| Title | Manufacturer | Date | Notes |
|---|---|---|---|
| FSCA: Updated labelling for single-use endoscopic stapler cartridges | Ethicon (J&J) | 03 Jan 2026 | Surgical device, unrelated device class and intended use. No overlap with patient monitoring. |
| FSCA: Recall of specific lot numbers of orthopaedic bone cement | Heraeus Medical | 18 Dec 2025 | Orthopaedic implant material. No device type, clinical domain, or mechanism overlap. |
| FSCA: IVD reagent shelf life reduction for HbA1c test kits | Roche Diagnostics | 02 Dec 2025 | In-vitro diagnostic reagent. Different regulatory framework (IVDR, not MDR). No relevance. |
| ... 39 more excluded items in full report | |||
This review identified 5 Field Safety Notices requiring attention (3 potentially relevant, 2 requiring further review). 42 notices were assessed as not relevant and excluded from further review. Appropriate follow-up actions should be taken in accordance with the applicable post-market surveillance plan.
AI Disclaimer: Relevance assessments in this report were produced by an AI language model (Anthropic Claude) and must be reviewed and approved by a qualified Person Responsible for Regulatory Compliance (PRRC) before inclusion in any Technical File, PMSR, or PSUR. AI outputs do not constitute a regulatory decision.
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