# AIRCHILL Safety Reporting Plan

> Development safety-reporting plan for adverse events, serious adverse events, adverse device effects, serious adverse device effects and device deficiencies in AIRCHILL clinical investigations.

- Canonical: https://www.medicalcooling.com/airchill-safety-reporting-plan/
- Markdown: https://www.medicalcooling.com/airchill-safety-reporting-plan/index.md
- Language: en-US
- Last modified: 2026-08-29T14:26:18+00:00

Safety governance · development plan v0.1

# AIRCHILL AE / SAE / Device Deficiency Reporting Plan

This plan defines the common safety workflow for AIRCHILL clinical investigations. Exact reporting deadlines and recipient lists must be finalised per jurisdiction, ethics committee, competent authority and FDA/IRB requirements before activation.

## 1. Event categories

- AE: any untoward medical occurrence after enrolment, whether device-related or not.
- SAE: death, life-threatening event, inpatient/prolonged hospitalisation, persistent/significant disability or other medically important serious event according to applicable definitions.
- Adverse device effect: AE related to use of the investigational device.
- Serious adverse device effect: serious event with at least a reasonable possibility of device/procedure relationship.
- Device deficiency: inadequacy in identity, quality, durability, reliability, safety or performance, including malfunction, use error or inadequate information.
- Unanticipated serious adverse device effect: serious device-related effect not adequately identified in nature, severity or incidence in the current risk information/IB.

## 2. Causality

Investigators assess relationship to AIRCHILL device, AIRCHILL procedure and other trial procedures separately using a controlled scale such as unrelated, unlikely, possible, probable, causal. Sponsor medical review may query but does not overwrite investigator assessment without audit trail.

## 3. Immediate site reporting

Sites report deaths, SAE, serious adverse device effects, unanticipated effects and serious device deficiencies to the sponsor immediately or within the protocol-defined rapid reporting window. Follow-up information is submitted until resolution/stabilisation or adequate explanation.

## 4. Special safety events of interest

- Clinically significant ventilation interruption or inability to maintain intended ventilation.
- Bronchospasm, airway pressure/resistance increase or gas-exchange deterioration.
- Arrhythmia or haemodynamic deterioration temporally associated with cooling.
- Suspected airway mucosal injury or secretion/condensation-related obstruction.
- Unexpected gas composition, FiO₂, temperature or humidity excursion.
- Stroke: any AIRCHILL-attributable delay to arterial puncture or reperfusion; symptomatic ICH.
- Cardiac arrest: unexpected imbalance in mortality, seizures or post-ROSC instability.

## 5. Device deficiency escalation

A deficiency is reported even without injury when recurrence could have led to SAE. Device is quarantined when appropriate; logs/telemetry/configuration are preserved; engineering investigation is linked to the clinical safety record; corrective actions are assessed for substantial-modification implications.

## 6. Expectedness

Expected adverse device effects are defined prospectively in the current Investigator’s Brochure and risk-management documentation. New information triggers prompt review of expectedness, consent materials, CIP, training and operating envelope.

## 7. Regulatory reporting

EU reporting follows MDR clinical-investigation requirements and applicable MDCG safety-reporting guidance/templates. US significant-risk investigations follow IDE sponsor/investigator reporting obligations and IRB requirements. Country-specific matrices must be appended before activation.

## 8. Safety reconciliation

Clinical database, serious-event tracker, device-deficiency log and DSMB dataset are reconciled at predefined intervals and before database lock. Discrepancies are resolved with audit trail.

## 9. Annual / periodic safety review

The sponsor periodically reviews cumulative event rates, seriousness, causality, expectedness, temporal pattern, dose relationship, device configuration and site clustering. Findings feed the IB, risk-management file, DSMB review and regulatory reports.

## 10. Emergency safety action

Immediate measures necessary to protect subjects may be implemented before prior approval where legally permitted; sponsor documents rationale, notifies required bodies and evaluates whether enrolment must pause or documents require amendment.

## 11. Safety CRF / SAE form template

FieldRequired content

Event ID / subject / siteUnique identifiers; no direct identifiers in central database.

Event term / diagnosisClinical diagnosis preferred over isolated symptom where available.

Onset / resolutionDate/time with relation to device start/stop.

SeverityProtocol-controlled severity scale.

SeriousnessDeath, life-threatening, hospitalisation/prolongation, disability, medically important event, other applicable criterion.

CausalitySeparate assessment for investigational device, AIRCHILL procedure and other study procedure.

ExpectednessExpected / unexpected against current IB reference safety information.

Device deficiencyY/N; malfunction/use error/alarm/other; could recurrence cause serious harm?

Action takenContinue, interrupt, stop, device replacement, treatment, emergency action.

OutcomeRecovered, recovering, unresolved, sequelae, death, unknown.

ReportingInvestigator awareness time, sponsor receipt time, ethics/authority/FDA/IRB reporting status and date.

[← Clinical Investigation Package](https://www.medicalcooling.com/airchill-clinical-investigation-package/)