QMS Platform/Quality Workspace

Customer Complaint Handling

QMSPost-Market Surveillance
Customer Incidents
Ticket IDCustomer & Problem Statement
Product / Lot
SeverityFDA ReportableStatusRisk Rating
CMP-2026-008
Kariadi General Hospital / Dept. Bedah

Konektor kabel daya unit mengalami kelonggaran kontak setelah 12 kali proses sterilisasi autoklaf suhu tinggi.

SmartDevicer™ Healer Pro (SD-H100)LOT-2026-0710
STANDARD DEFECTNoINVESTIGATING
25
CMP-2026-009
Singapore MedTech Consortium

Permukaan thread ulir screw nomor batch 0802 memiliki bekas oksidasi mikro saat dibuka di ruang steril.

Precision Titanium Bone Screw (TBS-04)LOT-2026-0802
HIGH MALFUNCTION Yes (MDR)ESCALATED CAPA
65