Jun 2021 : Initial Report for 2021-CC-EC-002 - Philips HeartStart Intrepid Monitor/Defibrillator (867172) - Possible interference with other monitoring devices
Initial Report for 2021-CC-EC-002 - Philips HeartStart Intrepid Monitor/Defibrillator (867172) - Possible interference with other monitoring devices
Affected Medical Device : HeartStart Intrepid Monitor/Defibrillator
MDA Reference Number : MDA/FCA/2021-P087
MDA Registration Number : GC2897720-42451
Decription : The HeartStart Intrepid Monitor/Defibrillator may cause interference on other monitoring devices when the other monitors and the Intrepid are connected to the same patient and the Intrepid is connected to AC power. This interference appears as distortion in the waveforms displayed on the other monitoring devices, which may interfere with the ability to promptly evaluate the patient status.
Local Establishment Contact Detail :
Zam Zarina Mat Ail
Quality & Regulatory Manager
Philips Health Systems Malaysia
Philips Malaysia Sdn. Bhd. Level 9, Menara Axis, No.2, Jalan 51A/223, 46100 Petaling Jaya, Selangor Darul Ehsan. MALAYSIA.
Email : [email protected]
