GS corPatch

Description of Event or Problem

On (b)(6) 2026, we have been informed about a malfunction with a defibrillation electrode set at the customer (b)(6) Rescue Department. GS defibrillation electrodes model 05120.5 CORPATCH EASY PRE-CONNECT (our model: DF53NC) and a GS defibrillator had been used.The initial report is stating that: "In the begining of resuscitation, right after when AED was activated (01:05:39) and the corPatch easy electrodes attached to patient there was no initial rhythm visible in the monitor screen. The monitor screen displayed dashed line. The ambulance crew immediately changed a new pair of corPatch easy electrodes. Corpuls gave an alarm message: "Connect cor Patch easy electrodes" ((01:08:07), the initial rhythm was visible on the monitor screen and they were able on analyze and defibrillate (01:09:07).I will send you the mission data (b)(4), trace log (b)(4) and corPatch easy electrodes used in this case via Pamark Finland to investigate was this incident due to malfunction of cor Patch easy electrodes or due to insufficient connection of master therapy cable and cor Patch easy electrodes.Corpuls 3T defibrillation functions were tested afterwards in ambulance station under EMS Supervisor guidance according to Corpuls manual. No malfunctions were detected. Device worked properly.Patient died at the scene (unsuccessful resuscitation)."We also have received a filled in questionnaire. It was stated that a patient had to be resuscitated. The female patient was described as of normal body type. The general condition and the skin type as normal. The patient was lying "horizontally on the floor". It was also reported that no skin preparation was performed, no shaving, no cleaning, no disinfection, but dried prior applying the defibrillation electrodes. The defibrillation "packaging was opened at the scene (at the beginning of the resuscitation)" and placed on the patient. It was reported that no impairment of the skin, no liquids were underneath the skin and the electrodes, no wrinkles or blisters form on the skin and no hair was visible present underneath the electrode at the site of application. It was also reported that the "electrodes sticked well" to the patient skin. The "first applied electrodes were used only 1 min 26 s before they were changed" and a "New pair of electrodes were taken into use. First pair did not work."It was also reported that "No clinical injury appearance" was noticed. No further details have been disclosed.We have requested the concerned defibrillation electrode set and the emergency data recorded by the defibrillator.No further details have been disclosed or received so far.

Additional Manufacturer Narrative

This product is not marketed in the USA. No 510 (k) and no PMA exists for it. However, devices made using a similar design are sold in the US. We are therefore reporting this incident.Retained samples of the concerned lot number 241005-4015 have been inspected visually and tested electrically. All tested electrodes were within their electrical limits.Currently we are awaiting the concerend defibrillation set for further investigation.We will provide further information, investigation results and any conclusion in a follow up report.