The list below contains Medical Device’s Field Corrective Action for the month of May 2024. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –

  • The return of the medical device to the establishment;
  • Modification of the medical device;
  • Exchange of the medical device;
  • Destruction of medical device; or
  • Specific advice on the use of the medical device. 

If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.

No

Date received

Title of FCA

Affected

Medical Device

MDA Reference Number

MDA Registration Number

Local Establishment

Contact Detail

1

03/05/2024

I pdf ABC Balloon Non-Inflation (391 KB)

AUTOCAT 3

MDA/FCA/P0780-87733439-2024

GD877091305219

SCHRENK CHARLES THOMAS

[email protected]

2

03/05/2024

I pdf ABC Balloon Non-Inflation (391 KB)

AUTOCAT 3

MDA/FCA/P0782-56685862-2024

GD9475223-139423

SCHRENK CHARLES THOMAS

[email protected]

3

03/05/2024

I pdf ABC Balloon Non-Inflation (391 KB)

ARROW AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM

MDA/FCA/P0783-84495139-2024

GD44414701118

SCHRENK CHARLES THOMAS

[email protected]

4

09/05/2024

  pdf Discoloration/corrosion inside the vaporizer sevoflurane (272 KB)

GETINGE FLOW-I ANESTHESIA SYSTEM

MDA/FCA/P0780-89749173-2024

GC25644700318

LIM WOON SUN

[email protected]

5

09/05/2024

  pdf Philips Interventional Hemodynamic Application R1.2.X, R1.3.0 and R1.3.1 Potential incorrect functional measurement (345 KB)

HEMODYNAMIC APPLICATION

MDA/FCA/P0787-87003714-2024

GB685291134018

CHAN JIN HOE

[email protected]

6

09/05/2024

  pdf Design update to the Model 8780, 8781 and 8784 Ascenda Intrathecal Catheters (Ascenda Catheter) (431 KB)

SYNCHROMED II PROGRAMMABLE PUMP SYSTEM AND ACCESSORIES

MDA/FCA/P0791-53584752-2024

GD6185822-96376

YAM KIN HUNG

[email protected]

7

10/05/2024

  pdf CORI Real Intelligence Field Action (196 KB)

REAL INTELLIGENCE CORI

MDA/FCA/P0792-63094108-2024

GB8636421-71478

CHEAM YOKE CHENG

[email protected]

8

11/05/2024

  pdf HeartMate System Monitor Atypical Behavior (434 KB)

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

MDA/FCA/P0789-81524008-2024

GD4151721-74880

YUMITRA A/P DHORAI RAJA

[email protected]

9

14/05/2024

  pdf VITROS® Chemistry Products ALKP and XT TBIL-ALKP Slides with Highly Elevated ALKP Concentrations Not Generating the Substrate Depletion Limit Code (119 KB)

VITROS CHEMISTRY PRODUCTS ENZYMES

MDA/FCA/P0795-64711289-2024

IVDB7737323-151303

MENG TSE LEEAU

[email protected]

10

15/05/2024

  pdf Replacement workflow with DBS Pocket Adaptor affecting MRI eligibility display (665 KB)

ACTIVA NEUROSTIMULATOR FOR DEEP BRAIN STIMULATION SYSTEM

MDA/FCA/P0799-56887119-2024

GD9997822-89709

YAM KIN HUNG

[email protected]

11

16/05/2023

  pdf Height Adjustable (HA) FlexTrak Trolley Potential falling hazard resulting from HA FlexTrak Trolley oil leakage (294 KB)

INGENIA 1.5T, INGENIA 3.0T

MDA/FCA/P0798

50059811-2024

GB63162332517

CHAN JIN HOE

[email protected]

12

16/05/2023

  pdf NovaStar TS and NovaStar plus - Possible impact of NovaStar masks with magnetic clips on medical implants (127 KB)

DRAEGER FULL FACE MASK NON-INVASIVE VENTILATION FACE MASKS

MDA/FCA/P0800-43591563-2024

GB7642222-99649

LESLIE LIEW WAI CHONG

[email protected]

13

16/05/2024

  pdf VITROS® Immunodiagnostic Products Anti-HBs Calibrators Instability May Lead to Positively Biased Patient and Quality Control Results (162 KB)

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS

MDA/FCA/P0801-38285635-2024

IVDD4213821-64864

MENG TSE LEEAU

[email protected]

14

24/05/2024

  pdf Incorrect Expiration Date Assigned to VITROS® Chemistry Products Calibrator Kit 29, Lot 2953 (133 KB)

VITROS IMMUNOCHEMISTRY ANEMIA

MDA/FCA/P0808-24838188-2024

IVDB7591723-145140

MENG TSE LEEAU

[email protected]

15

24/05/2024

  pdf Certain drug and fluid administration details may be missing from Trend View in the Centricity High Acuity Anesthesia (CHA A) system (734 KB)

CENTRICITY HIGH ACUITY ANESTHESIA

MDA/FCA/P0810-56281422-2024 

GMD29146275517A

LIM SOCK SIANG

[email protected]

16

27/05/2024

  pdf Potential for serious injury or death resulting from failure of the telescopic arm anti-fall mechanism. (1.04 MB)

MOBILE DIAGNOST WDR

MDA/FCA/P0804-83721267-2024

GC94902489117

CHAN JIN HOE

[email protected]

17

27/05/2024

VITEK® 2 - AST Test Kits

Incorrect Ceftriaxone Concentrations

VITEK® 2 ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) CARD               

MDA/FCA/P0812-89961089-2024

IVDB7784623-128365

MICHAEL CONLON

[email protected]

18

27/05/2024

  pdf BIOFIRE TORCH Base Power Supply (297 KB)

BIOFIRE FILMARRAY INSTRUMENTS

MDA/FCA/P0813-18352663-2024

IVDB8826823-128366

MICHAEL CONLON

[email protected]