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Jun 2021 : Initial Report for 2021-CC-EC-002 - Philips HeartStart Intrepid Monitor/Defibrillator (867172) - Possible interference with other monitoring devices
Dikunjungi: 8676
Jun 2021 : FCA_DTG_Intuitive Surgical ISIFA2021-01-C : da Vinci® S/Si Harmonic Ace Reprocessing Instructions For Use (IFU)
Dikunjungi: 9121
Jun 2021 : Corrective action reporting for FMI 36149 : CARESCAPE PDM – Masimo SpO2 Saturation Values can become frozen after an extended length of usewithout a power down.
Dikunjungi: 10440
Jun 2021 : Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.
Dikunjungi: 7951
Jun 2021 : POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.
Dikunjungi: 3823
Jun 2021 : Corrective action reporting for FMI 34118 : URGENT MEDICAL DEVICE CORRECTION - Turbine Over temperature alarm/failure,a buildup of PEEP higher than set values, and Plateau Pressure inaccuracy could occur on Siaretron 4000T and Falco 202 Evo Ven
Dikunjungi: 3560
Jun 2021 : Field Safety Notice 92705305-FA – High Battery Impedance May Initiate Safety Mode in INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Dikunjungi: 6375
Jun 2021 : Notification of Field Action: INGENIO 2 (ESSENTIO, PROPONENT) PACEMAKER, Ingenio 2 (Valitude, Valitude X4, Visionist, Visionist X4 CRT-P)
Dikunjungi: 3372
Jun 2021 : Field Safety Notification on Access CEA (FA-000602) : Duplicate lot numbers for current and expired Access CEA reagent packs.
Dikunjungi: 5440
Jun 2021 : CVG-22-Q1-04 Heartware Ventricular Assist System (HVAD) System : Notify customers on stop distribution and sale
Dikunjungi: 3716
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Halaman 15 dari 16
Utama
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Hubungi Kami
Carta Organisasi
Code of Ethics and Conduct
Board of Directors
Top Management Team of MDA
Malaysian Leadership
Former CEO of MDA
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Kajian Kepuasan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Laporan Tahunan
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