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FIELD CORRECTIVE ACTION LISTING FOR APRIL 2024
The list below contains Medical Device’s Field Corrective Action for the month of April 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 |
01/04/ 2024 |
Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS) Failures |
PHILIPS INTELLIVUE INFORMATION CENTER IX APPLICATION SW |
GC56105716618 |
CHAN JIN HOE |
|
|
2 |
03/04/2024 |
VAD Autologs Feature and Update Regarding HVAD Power Source Management |
HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD) |
GD74345985518 |
YAM KIN HUNG |
|
|
3 |
03/04/2024 |
Spectral CT Reflective Laser Line May Lead to Misdiagnosis and Subsequent Incorrect Treatment |
SPECTRAL CT |
GC6307722-96412 |
CHAN JIN HOE |
|
|
4 |
05/04/2024 |
BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro Interruptions and/or loss of therapy due to a Ventilation Inoperative Alarm |
BIPAP A30 VENTILATOR |
GC35643583518 |
CHAN JIN HOE |
|
|
5 |
19/04/2024 |
"SpO2 probe failure" message is displayed |
BEDSIDE MONITOR BSM-1700 SERIES |
GC59413261717 |
AZURA JAAFAR |
|
|
6 |
05/04/2024 |
BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro Interruptions and/or loss of therapy due to a Ventilation Inoperative Alarm |
BIPAP A40 VENTILATOR |
GC65940156417 |
CHAN JIN HOE |
|
|
7 |
05/04/2024 |
OmniLab Advanced + (OLA+) Interruptions and/or loss of therapy due to a Ventilation Inoperative Alarm |
OMNILAB ADVANCED + SYSTEM |
GC27429545218 |
CHAN JIN HOE |
|
|
8 |
19/04/2024 |
"SpO2 probe failure" message is displayed on the device |
BEDSIDE MONITOR CSM-1000 SERIES |
GC910451285919 |
AZURA JAAFAR |
|
|
9 |
08/04/2024 |
StealthStation™ S8 App versions 1.0.1, 1.0.2, 1.0.3, 1.1.0, 1.2.0 (Model # 9735762) StealthStation™ S8 Application – Missing Character in Banner Text |
STEALTHSTATION S8 CRANIAL SYSTEM |
GC7686023-140750 |
YAM KIN HUNG |
|
|
10 |
08/04/2024 |
StealthStation™ S8 App versions 1.0.1, 1.0.2, 1.0.3, 1.1.0, 1.2.0 (Model # 9735762) StealthStation™ S8 Application – Missing Character in Banner Text |
STEALTHSTATION FLEXENT SYSTEM |
GC6421521-58428 |
YAM KIN HUNG |
|
|
11 |
08/04/2023 |
StealthStation™ S8 App versions 1.0.1, 1.0.2, 1.0.3, 1.1.0, 1.2.0 (Model # 9735762) StealthStation™ S8 Application – Missing Character in Banner Text |
STEALTHSTATION S8 ENT SYSTEM |
GC771281137418 |
YAM KIN HUNG |
|
|
12 |
12/04/2023 |
Order-based medication mixture details may be confusing in Centricity High Acuity Anesthesia (CHA A) and Centricity High Acuity Critical Care (CHA CC) systems (collectively CHA). |
Centricity High Acuity Critical Care |
IVDB5289622-97895 |
LIM SOCK SIANG |
|
|
13 |
17/04/2024 |
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. |
ROBOTIC ARM INTERACTIVE ORTHOPAEDIC SYSTEM (RIO) |
GC593731188118 |
LIM CHING HUEI |
|
|
14 |
19/03/2024 |
AutomaticQC Cartridge Kit Level 3 pH Recovering High on RAPIDLab 1200 Blood Gas Systems |
RAPIDPOINT 500 |
IVDC6984796818 |
FRAZER RODERICK JOHN |
|
|
15 |
19/04/2024 |
False positive patient test results with Xpert® Carba-R (GXCARBARP-CE-10 batch 1001208183 lot 10808) kits |
XPERT CARBA-R |
IVDC53630206318 |
HOR ZIAN KHANG |
|
|
16 |
19/04/2024 |
Incisive CT/CT 3500/CT 5300 System Potential for System Shutdown and Expelled Parts |
INCISIVE CT |
GC74519972618 |
CHAN JIN HOE |
|
|
17 |
19/03/2024 |
ProBP 3400, VS100 SVS, Stand-alone Power Cords |
WELCH ALLYN SPOT VISION SCREENER |
MDA/FCA/P0759-70791042-2024 |
GB6425422-87993 |
JASON LEE CHIA YII |
|
18 |
24/04/2024 |
ProBP 3400, VS100 SVS, Stand-alone Power Cords |
WELCH ALLYN PROBP 3400 |
GB22125572518 |
JASON LEE CHIA YII |
|
|
19 |
22/04/2024 |
Infinity Acute Care System - Infinity M500 Docking Station is not in full compliance to type CF requirements |
DRAEGER INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION |
GC28280820118 |
LESLIE LIEW WAI CHONG |
|
|
20 |
26/04/2024 |
Analyte has increased over the shelf life of the product and requires the targets and ranges to be reassigned. |
HUMAN ASSAYED MULTI-SERA |
IVDC53152117318 |
MOURAD KHOLTI |
|
|
21 |
26/04/2024 |
VITROS® Immunodiagnostic Products HIV Combo Control (HIV p24 Antigen) Not Stable Up To 13 Weeks When Stored at 2-8°C |
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO |
IVDD7178222-90123 |
MENG TSE LEEAU |
|
|
22 |
26/04/2024 |
Target value update for DiaSys controls |
SODIUM FS |
IVDB52958290618 |
CHEAH KIT YIN |
|
|
23 |
29/04/2024 |
Reusable Tip Clip Sensor |
BP-200 PLUS |
GB72718125917 |
LIM THIAM HONG |
|
|
24 |
30/04/2024 |
MR systems terminal connections in the general Mains Distribution Unit (g-MDU) may produce a Thermal Event |
ACHIEVA SERIES |
GB44884842218 |
CHAN JIN HOE |
|
|
25 |
30/04/2024 |
MR systems terminal connections in the general Mains Distribution Unit (g-MDU) may produce a Thermal Event |
INGENIA 1.5T, INGENIA 3.0T |
GB63162332517 |
CHAN JIN HOE |
|
|
26 |
30/04/2024 |
MR systems terminal connections in the general Mains Distribution Unit (g-MDU) may produce a Thermal Event |
INGENIA CX |
GB25631685418 |
CHAN JIN HOE |
|
|
27 |
30/04/2024 |
MR systems terminal connections in the general Mains Distribution Unit (g-MDU) may produce a Thermal Event |
MR 5300 |
GB2458922-104130 |
CHAN JIN HOE |
|
|
28 |
30/04/2024 |
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and Certain Versions of CARESCAPE B850, or CARESCAPE B650 Monitors |
CARESCAPE CANVAS PATIENT MONITORS |
GC9975923-151743 |
LIM SOCK SIANG |
