Operational queue
This is now workflow-first, not explanatory-first. Every row is an actionable case state.
Obligation clocks
Stage 1 facility reporting live
Mandatory reporting commenced on 21 March 2026 for the first stage. Use route decision and proof capture where a reportable adverse event or near miss exists.
PB980 watch/pre-case
FDA Class I recall open; AU public action for the same 2022 issue not confirmed here. Local serial matching and sponsor challenge decide exposure first.
UDI readiness
Class III and IIb device UDI obligations start from 1 July 2026. Keep device master and local identifiers ready even where serial-based closure still depends on BMMS data.
Watch / pre-case queue
Signals here are not yet authoritative AU market actions.
Add watch signal
Create or escalate case
Current case register
Serial matching engine
Paste hospital inventory CSV rows in the format: serial,site,location,status.
Five-bin results
Action tracker
Add action
Submission proof register
Saved proof records
Closure review
Closure state
Audit pack preview
Generate a concise, testable pack from live case state.
Global-to-AU watch resolver
Use when a foreign or sponsor signal arrives first.
Device ARTG-linked?
Yes for PB980 (ARTG 221416). This is the pivot that upgrades a foreign signal into an AU-linked pre-case.
Public AU action confirmed?
Not required for initial watch state. Required to classify as authoritative AU market action.
Resolution policy
Watch
FDA or sponsor signal only.
AU-linked pre-case
ARTG-linked product family confirmed.
Immediate action
Local critical-care risk justifies pre-agreement mitigations.
Testing instruction
Do not overclaim this module publicly. It is part of the production testing shell and internal ops logic first.
Sponsor challenge tracker
Internal SLA clock for operational governance. This is platform policy, not a legislated TGA deadline.
| Field | Value |
|---|---|
| Challenge date | 2026-03-30 |
| Sponsor | Medtronic Australasia Pty Ltd |
| Initial response SLA | 5 business days |
| Serial confirmation SLA | 10 business days |
| Question set | Are these serials in AU supply, which customers hold them, was AU action initiated, and what interim instructions apply? |
Send challenge
Immediate Action mode
For ICU or other critical-care cases where imminent risk is judged locally.
48-hour clock progress (testing stub).
Interim controls
Use instructions
Keep visual alarm banner visible, ensure staff understand degraded alarm pathway, and transfer patient to alternate ventilation if the audible alarm or omni-directional LED fails.
Escalation
Notify biomedical engineering, ICU leadership, and governance immediately when a matched serial is located in active service.
Open recall aging monitor
| Threshold | Status | Action |
|---|---|---|
| 90 days | Exceeded | Request sponsor confirmation |
| 1 year | Exceeded | Escalate unresolved AU exposure |
| 2 years | Exceeded | Executive review |
| 4 years | Current PB980 state | Proof-of-need anchor |
Why this module exists
An open foreign recall for an ARTG-linked device family, with unresolved root cause and no confirmed local closure state, is exactly the type of case that justifies the platform’s operational bridge.