Datasets:

protocolsyncllc
/

field-safety-notices

+{"instruction":"Audit the design and development documentation for active devices to ensure that alarm systems are designed to prevent nuisance alarms that could mask critical patient safety warnings, in accordance with Annex I Section 18.","context":"The design verification report for the medin-NC3 device indicates that the alarm logic for temperature monitoring was not updated to account for the new HY-LINE H2B665 battery configuration. The document notes that software versions prior to CPU V1.2 may interpret battery parameters incorrectly, leading to persistent medium-priority alarms that cannot be cleared by user acknowledgment. There is no record of a risk assessment evaluating the impact of these nuisance alarms on the user's ability to respond to genuine critical alarms.","response":"Field Safety Notice 30339/26 issued by BfArM on 2026-08-10 reported that false/nuisance medium-priority temperature alarms were issued for the medin-NC3 for Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply. This violates Annex I Section 18.4 of Regulation (EU) 2017/745, which requires devices intended to monitor clinical parameters to be equipped with appropriate alarm systems to alert the user of situations that could lead to death or severe deterioration. The technical failure is the lack of software compatibility with the new battery, which generates unacknowledgeable nuisance alarms, thereby compromising the reliability of the alarm system and potentially desensitizing users to critical alerts."}
+{"instruction":"Review the design and risk management file for the Carestation 850 anesthesia system to ensure compliance with Annex I.18 regarding active devices and power supply safety.","context":"The design specification for the Carestation 850 does not include a redundant power supply or a battery backup system to maintain ventilation during AC mains power loss. The risk assessment document classifies the loss of ventilation during power failure as a low-probability event and does not require an alarm system to signal the power failure to the user. The IFU instructs users to manually switch to backup ventilation but does not provide a time-critical warning for the transition, leaving a gap in the safety design.","response":"Field Safety Notice 40703/26 issued by BfArM on 2026-08-31 reported that unexpected shutdowns caused by incomplete startup or power loss disrupted gas flow and ventilation for Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply. This violates Regulation (EU) 2017/745 Annex I, Section 18.3 and 18.4, which require devices dependent on external power to include an alarm system for power failure and devices monitoring clinical parameters to have appropriate alarm systems to alert users of situations leading to severe deterioration. The technical failure is the lack of an inherent safety mechanism (such as a battery backup or immediate audible/visual alarm) to prevent or mitigate the life-threatening loss of ventilation during a power interruption or startup error."}
+{"instruction":"Review the design and risk management documentation for the Leoni plus ventilators to ensure compliance with Annex I.18 regarding the prevention of fire risks and single fault conditions in active devices.","context":"The design file for the Leoni plus ventilator does not include a thermal management analysis for the electronic components under continuous standby operation. The risk assessment states that overheating is a 'theoretical' risk and that users are responsible for monitoring the device temperature. No automatic shutdown or alarm system is implemented to detect internal overheating of the electronic components.","response":"Field Safety Notice 28352/26 issued by BfArM on 2026-09-02 reported that an electronic component in the LEONI plus, LEONI plus HFO, and LEONI plus transport ventilators may overheat internally, and prolonged overheating can lead to impaired functionality or device failure, smoke generation, and in the worst case, a fire for Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply. This violates Regulation (EU) 2017/745 Annex I, Section 18, specifically 18.1, which requires appropriate means to eliminate or reduce risks in the event of a single fault condition, and general safety requirements regarding fire prevention. The technical failure is the absence of a thermal monitoring or automatic shutdown mechanism for the electronic components, relying solely on user vigilance to prevent a single fault (overheating) from escalating to a severe hazard (fire), which is insufficient for a life-support device."}
+{"instruction":"Assess the adequacy of the field safety notice instructions for the Leoni plus ventilators, specifically regarding the mitigation of overheating risks through user behavior.","context":"The field safety notice instructs operators to not leave devices in standby mode and to turn them off completely when not in use. The notice states that devices may remain connected to power for battery charging only if turned off. The manufacturer did not provide any technical modification or software update to address the root cause of the overheating electronic component.","response":"Field Safety Notice 28352/26 issued by BfArM on 2026-09-02 reported that operators are instructed not to leave devices in standby mode and to turn them off completely when not in use to mitigate the risk of overheating, and devices may remain connected to power for battery charging only if turned off for Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply. This violates Regulation (EU) 2017/745 Article 89(8), which requires the field safety notice to clearly indicate all actions to be taken by users to minimize risk, and Article 89(3) regarding the evaluation of the adequacy of the corrective action. The logical failure is the reliance on user behavior (turning off the device) as the sole corrective action for a design defect (overheating component); this does not address the root cause and places the burden of safety on the user, which is inadequate for a critical care device where standby mode is often necessary for rapid deployment."}
+{"instruction":"Review the Field Safety Corrective Action (FSCA) procedure to ensure that the reporting timeline to the competent authority aligns with the severity of the incident and the specific deadlines mandated by EU MDR Article 87.","context":"The QMS document states that for medium-risk field safety corrective actions, the manufacturer may submit the report to the competent authority within 30 days of initiating the action. The procedure does not distinguish between urgent and non-urgent scenarios, nor does it specify the requirement to report in advance of the action being undertaken. There is no mention of the 15-day or 2-day reporting windows for serious incidents or public health threats.","response":"Field Safety Notice 28352/26 issued by BfArM on 2026-09-02 reported that service providers are required to check all gas mixers in stock and inspect affected devices for Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply. This violates Article 87(1)(b) and Article 87(8) of Regulation (EU) 2017/745, which require manufacturers to report field safety corrective actions without undue delay and, except in cases of urgency, in advance of the action being undertaken. The QMS gap lies in the failure to define the 'without undue delay' timeframe and the omission of the pre-implementation reporting requirement, which is critical for ensuring competent authorities can evaluate the risk before the corrective action is deployed in the field."}