BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G3 AED DEFIBRILLATION PADS

    MDR report key: 9501362 · Received December 20, 2019

    Report

    Report Number
    2112020-2019-00026
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 28, 2019
    Report Date
    February 18, 2020
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    UDI-DI
    00812394020911
    PMA / PMN Number
    P160033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PADS THE PARAMEDIC HAD STARTED TO OPEN DURING THE RESCUE EVENT WERE RECEIVED ALONG WITH 6 SETS OF UNOPENED PADS FROM THE SAME LOT. WHEN THE CUSTOMER REPORTED THE EVENT THEY PROVIDED A PICTURE OF THE PAD THEY ATTEMPTED TO USE WHICH SHOWED THE GEL HAD FOLDED OVER ONTO ITSELF AND BECOME DETACHED FROM THE EDGE OF THE ELECTRODE. THE SECOND PAD, WHICH HAD NOT BEEN REMOVED FROM THE RELEASE LINER DURING THE RESCUE, WAS PEELED FROM THE LINER AS PART OF CARDIAC SCIENCE'S EVALUATION. THE PAD PEELED AWAY FROM THE LINER WITHOUT PROBLEMS AND THE GEL DID NOT PULL AWAY FROM THE ELECTRODE. THE FOAM BACKING MATERIAL OF THE PAD WITH THE DETACHED GEL WAS STRETCHED WHICH INDICATED THE PAD HAD LIKELY BEEN PEELED FROM THE RELEASE LINER INCORRECTLY. IF PADS ARE NOT PEELED FROM THE RELEASE LINER AS DIRECTED BY THE LABELING THEY CAN BE DAMAGED AND THE GEL MAY DETACH FROM THE ELECTRODE. THIS IS THE ONLY REPORTED PROBLEM FOR PADS FROM LOT 190812-08. SEVEN (7) SETS OF REPLACEMENT PADS WERE SENT TO THE CUSTOMER.

    Description of Event or Problem · 0

    A DISTRIBUTOR NOTIFIED CARDIAC SCIENCE OF AN INCIDENT THEY RECEIVED FROM AN AMBULANCE SERVICE IN SWEDEN. CPR WAS STARTED ON THE PATIENT BY THE FAMILY. THE AMBULANCE SERVICE ARRIVED AT THE SCENE AND WHEN THE PARAMEDIC STARTED OPENING THE PADS PRIOR TO PLACEMENT ON THE PATIENT, THE PARAMEDIC NOTICED THE GEL WAS SEPARATING FROM THE PADS. THE AMBULANCE SERVICE USED ANOTHER SET OF PADS TO TREAT THE PATIENT. THE PATIENT DID NOT SURVIVE.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR HAS THE PADS USED DURING THE EVENT IN THEIR POSSESSION AND WILL SEND THEM TO CARDIAC SCIENCE FOR EVALUATION. THE CUSTOMER FOUND ADDITIONAL PADS FROM THE SAME LOT AND THESE WILL BE SENT TO THE DISTRIBUTOR WHO WILL FORWARD THEM TO CARDIAC SCIENCE.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED CARDIAC SCIENCE OF AN INCIDENT THEY RECEIVED FROM AN AMBULANCE SERVICE IN (B)(6). CPR WAS STARTED ON THE PATIENT BY THE FAMILY. THE AMBULANCE SERVICE ARRIVED AT THE SCENE AND WHEN THE PARAMEDIC STARTED OPENING THE PADS PRIOR TO PLACEMENT ON THE PATIENT, THE PARAMEDIC NOTICED THE GEL WAS SEPARATING FROM THE PADS. THE AMBULANCE SERVICE USED ANOTHER SET OF PADS TO TREAT THE PATIENT. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300804 POWERHEART G3 AED DEFIBRILLATION PADS DEFIBRILLATION ELECTRODES MKJ CARDIAC SCIENCE CORPORATION 9131-001 190412-08 00812394020911

    Patients

    Seq Age Sex Outcome Treatment
    1 Death