FDA expands external defib recall to 280K devices
The FDA has expanded an external defibrillator Class 1 recall, suggesting that about 280,000 devices could malfunction due to faulty components of 14 models made by Cardiac Science when used on patients experiencing sudden cardiac arrest.
According to the agency, the faulty components in defibrillators manufactured by Cardiac Science, of Bothell, Wash., may cause the devices to fail to properly deliver a shock. Other problems with the affected models may include interruption of electrocardiography analysis, failure to recognize electrode pads and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
In addition, Cardiac Science issued a software upgrade for the devices’ self tests on Feb. 24 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. The original recall was issued in February.
However, the FDA’s review of the updated software indicated that it detects some but not all electrical component defects. Updated recommendations and a complete list of affected models can be found in the Medical Device Update on Feb. 27.
According to the agency, the faulty components in defibrillators manufactured by Cardiac Science, of Bothell, Wash., may cause the devices to fail to properly deliver a shock. Other problems with the affected models may include interruption of electrocardiography analysis, failure to recognize electrode pads and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
- CardioVive models 92531, 92532 and 92533
- Nihon Kohden models 9200G and 9231 and
- GE Responder models 2019198 and 2023440.
In addition, Cardiac Science issued a software upgrade for the devices’ self tests on Feb. 24 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. The original recall was issued in February.
However, the FDA’s review of the updated software indicated that it detects some but not all electrical component defects. Updated recommendations and a complete list of affected models can be found in the Medical Device Update on Feb. 27.