FIELD CORRECTIVE ACTION (FCA) LISTING FOR MAY 2022

The list below contains Medical Device’s Field Corrective Action for the month of May 2022. 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.

Date received	Title of FCA	Affected Medical Device	MDA Reference Number	MDA Registration Number	Description	Local Establishment Contact Detail
6 May 2022	FCA on Recommendation of field replacement batteries distributed on or after April 1, 2019, for Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View can potentially fail earlier than their estimated life.	Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View	MDA/FCA/2022-P071	GC72098321117	Backup batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019, and GE Healthcare recommended field replacement batteries distributed on or after April 1, 2019, for Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View can potentially fail earlier than their estimated life.	Benedict Lee Regulatory leader GE Healthcare Sdn Bhd
6 May 2022	FCA on the quality issue detectedwith the IH-QC 3 lot 08730 72 1. with the IH-QC 3 lot 08730 72 1.	IH-QC 3	MDA/FCA/2022-P072	IVDD98265123918	Following customers' feedback, we have been able to confirm that the results obtained with this IH-QC 3 batch may not be as expected	Ng Boon Thiam Biomarketing Services (M) Sdn Bhd
9 May 2022	FCA on the releasing of a new software version 5.0 for the Alinity h-series.	Alinity hq Analyzer Alinity hs Slide Maker Stainer Module	MDA/FCA/2022-P073	IVDB31515121518 IVD59405672818A	Abbott Hematology is releasing new software version 5.0 for the Alinity h-series.	Farah Syuhaidah binti Ahmad Jahiddin Regulatory Affairs & Quality Assurance Executive Abbott Laboratories (M) Sdn. Bhd.
9 May 2022	FCA on obstructed breathing system filter of SafeStar 55	SafeStar 55	MDA/FCA/2022-P074	GB38309650818	Dräger has become aware of one case in which an obstructed breathing system filter SafeStar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated.	Beatrice Mah QRA Specialist Draeger Malaysia Sdn Bhd
10 May 2022	FCA on Centricity - two potential issues where inaccurate Distance and Area measurements can be displayed	Centricity Universal Viewer Zero Footprint Client, Centricity PACS RA1000 Workstation Centricity Radiology RA600 Centricity Cardiology CA1000 Centricity Enterprise Web	MDA/FCA/2022-P075	GB55729465417 GB71424485717	GE Healthcare has become aware of two potential issues where inaccurate Distance and Area measurements can be displayed.	Benedict Lee Regulatory leader GE Healthcare Sdn Bhd
10 May 2022	FCA on SOPHIE Ventilator - the external trigger in invasive SIMV ventilation with flow sensor switched OFF triggers a mechanical breath.	SOPHIE Ventilator	MDA/FCA/2022-P076	GC26518721818	When using the external trigger in invasive SIMV ventilation with flow sensor switched OFF, it is possible that, due to software anomally, every spontaneous breath detected triggers a mechanical breath.	Jack Chan Regional Technical Support Engineer Fritz Stephan Southeast Asia Sdn Bhd .
18 May 2022	Notification of FCA on 1688 4K Camera Control Unit with Advanced Imaging Modality - software defect in the 1688 CCU that may cause the image on the monitor to flip upside-down into an incorrect orientation	1688 4K Camera Control Unit with Advanced Imaging Modality	MDA/FCA/2022-P078	GA1026461936035	A software defect has been identified in the 1688 CCU that may cause the image on the monitor to flip upside-down into an incorrect orientation	Choo Wan Kee Senior RA Specialist Stryker Corporation (Malaysia) Sdn Bhd
23 May 2022	Initial FCA Report on Absolute Pro LL Peripheral Self-Expanding Stent System (PSESS) - mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent	Absolute Pro LL Peripheral Self-Expanding Stent System (PSESS)	MDA/FCA/2022-P079	GD62311692918	Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.	Chanakan Deekiatlum QA Specialist Abbot Medical (M) Sdn Bhd
27 May 2022	FCA Notification on The CARESCAPE Central Station (CSCS) V2 - can shut down due to a potential power supply component failure.	GE CARESCAPE Central Station	MDA/FCA/2022-P081	GC53550811918	The CARESCAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure.	Benedict Lee Regulatory leader GE Healthcare Sdn Bhd