08 · PMS · ORACLE · WORKBENCH
Post-market surveillance · signal monitor
PMCF 312/455 · 1 FSCA pending · Sydney battery cluster 4.2σ
Agent reasoning trace · ORACLE
4.2σ Sydney battery cluster auto-detected (B-2026-04-AU)auto…02a4
17 May 03:14 AESTReportable-event workflow auto-instantiatedauto…02b1
17 May 03:15 AESTFSCA cross-jurisdiction 7-day clock armedarjn…1708
17 May 08:40 AESTSignal monitor · 28-day rolling z-score
Sydney battery cluster4.2σ · ESCALATED
HK device syncnominal
SG insertion erythemaresolved
Global AE baseline2.3% · within envelope
FSCA queue
FSCA-LINQ-NEXT-001PENDING · AU
CROSS-JURIS CLOCK7-day notification armed
TGA DECISIONby 24 May
POLICYPOL-CROSS-PMS-V1
PMCF cohort
312 / 455 enrolled · first 30 per market
ENROLLED312 of 455
ACTIVE MARKETSHK · SG
MILESTONE30 units / market
PSUR3-yr template · next due Q3 2026
Governance
Receipt chain
Sydney 4.2σ signalauto…02a4
Reportable workflowauto…02b1
Human sign-offs
ORACLE · auto-escalation17 May · ⬢
Tomás Ribeiro · PMS reviewpending
Framework parity
POL-REPORTABLE-EVENT-V2POL-CROSS-PMS-V1POL-PMCF-V3TGA