Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2019-RN-00702-1
Product Name/Description Various Schiller Defibrillation Electrodes

Supplied both individually and with Defigard and FRED easy defibrillators

Product Codes (individual supply): 0-21-0003, 2.230342, 0-21-0020, 2.155061, 0-21-0037, 2.230347, 2.155067 and 0-21-0040

Multiple Lot Numbers

Impacted Defibrillator Product Codes : 1.8004, 1-58-9501 and 2.1155067

ARTG: 174306
(Intermed Medical Pty Ltd - Defibrillator/pacemaker)
Recall Action Level Consumer
Recall Action Classification Class I
Recall Action Commencement Date 16/05/2019
Responsible Entity Intermed Medical Pty Ltd
Reason/Issue Two complaints were received regarding a malfunction during use and a subsequent investigation discovered that electrode material had been caught between a rivet and the ring terminal of the electrode cable leading to no or only intermittent electrical contact between the electrode and the defibrillator.

There is a potential risk that no signals or energy will be transmitted. This can result in failure to treat a patient in a life-threatening condition requiring a defibrillation shock on time.
Recall Action Recall
Recall Action Instructions Intermed is advising customers to inspect inventory and quarantine impacted product codes / lot numbers.

Following receipt of replacement electrodes, customers are requested to destroy affected stock.

This action has been closed out on 25/10/2019
Contact Information 1300 123 633 - InterMed Medical