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70-02053-31 A
Powerheart® AED G3 Elite 9790A and 9790E
Introduction
Potential adverse effects of the device on health
Below is a list of the potential adverse effects (e.g., complications)
associated with the use of the device and AEDs in general, listed
in decreasing order of seriousness:
◆
Failure to identify shockable arrhythmia;
◆
Failure to deliver a defibrillation shock in the presence of
VF or pulseless VT, which may result in death or permanent
injury;
◆
Inappropriate energy which could cause failed defibrillation
or post-shock dysfunction;
◆
Myocardial damage;
◆
Fire hazard in the presence of high oxygen concentration or
flammable anesthetic agents;
◆
Electromagnetic interference (EMI) from the defibrillator
impacting other devices especially during charge and
energy transfers;
◆
Incorrectly shocking a pulse sustaining rhythm and inducing
VF or cardiac arrest;
◆
Bystander shock from patient contact during defibrillation
shock;
◆
Interaction with pacemakers;
◆
Skin burns around the electrode placement area;
◆
Allergic dermatitis due to sensitivity to materials used in
electrode construction; and
◆
Minor skin rash.
