December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.

Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.

 

 

Affected Medical Device : DEFIGARD Touch 7

 

MDA Reference Number : MDA/FCA/2021-P173

 

MDA Registration Number : GC11767462517

 

Description :

Possible that a defibrillation shock cannot be delivered, the device shows an electrode failure although no electrode failure is present. This results in an internal safety discharge, the shock delivery is cancelled.

 

Local Establishment Contact Detail :

Nurul Nadiah
Regulatory Affairs and Quality Executive
Phone +603 6272 3033
SCHILLER ASIA PACIFIC
No. 10 Jalan Ara SD 7/3B, Bandar Sri Damansara,52200 Kuala Lumpur, Malaysia

 

Email : nurul.nadiah@schiller.com.my

 

 A copy of FSN.