BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART G5 AUTOMATIC AED

    MDR report key: 7979805 · Received October 18, 2018

    Report

    Report Number
    2112020-2018-00020
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Report Date
    May 31, 2019
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PMA/510(K) NUMBER CHANGED FROM K143714 TO P160033. DEVICE EVALUATION: THE AED WAS RECEIVED AND AN INVESTIGATION WAS PERFORMED. A TEST BATTERY WAS INSTALLED INTO THE AED AND THE RESCUE READY INDICATOR DID NOT CHANGE TO GREEN. AFTER THE AED'S LID WAS OPENED, THE DEVICE PROMPTED SERVICE REQUIRED AND THERE WAS A PADS ERROR. A COMMUNICATION CABLE WAS ATTACHED AND THE AED WAS UNABLE TO COMMUNICATE WITH A COMPUTER. THE AED WAS OPENED AND INSPECTION FOUND SIGNIFICANT DAMAGE TO THE MAIN PCBA BOARD. THERE WERE BURNT COMPONENTS AND SOME RESISTORS HAD COME OFF THE MAIN PCBA BOARD. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS HEAVY DAMAGE TO THE HIGH VOLTAGE CIRCUIT. THE INVESTIGATION WAS COMPLETED AND THE AED WILL BE SCRAPPED.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN HONG KONG REPORTED THEIR SALES PERSON TOOK A G5 DEMO AED TO A CLIENT FOR A DEMONSTRATION. THE AED WAS CONNECTED TO A SIMULATOR AND DURING THE DEMONSTRATION THE AED GAVE A SHOCK AND SMELLED "BURNT". AFTERWARDS THE AED INDICATED SERVICE WAS REQUIRED. WHEN THE AED WAS CONNECTED TO A COMPUTER THE DATA FILE COULD NOT BE DOWNLOADED WITH AED MANAGER. THE REPORTED PROBLEM DIDN'T CAUSE ANY INJURIES.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR WAS ASKED TO RETURN THE AED TO CARDIAC SCIENCE FOR INVESTIGATION AND SERVICE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THEIR SALES PERSON TOOK A G5 DEMO AED TO A CLIENT FOR A DEMONSTRATION. THE AED WAS CONNECTED TO A SIMULATOR AND DURING THE DEMONSTRATION THE AED GAVE A SHOCK AND SMELLED "BURNT". AFTERWARDS THE AED INDICATED SERVICE WAS REQUIRED. WHEN THE AED WAS CONNECTED TO A COMPUTER THE DATA FILE COULD NOT BE DOWNLOADED WITH AED MANAGER. THE REPORTED PROBLEM DIDN'T CAUSE ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822846 POWERHEART G5 AUTOMATIC AED AUTOMATED EXTERNAL DEFIBRILLATOR (AED) MKJ CARDIAC SCIENCE CORPORATION G5A

    Patients

    Seq Age Sex Outcome Treatment
    1