BEUDAMED
    FDA Adverse Event Summary report: N

    POWERHEART

    MDR report key: 3123860 · Received April 1, 2013

    Report

    Report Number
    3123860
    Date Received
    April 1, 2013
    Date of Event
    November 30, 2012
    Report Date
    April 1, 2013
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    WHEN TRYING TO REPLACE EXPIRING AED PADS FOUND PRODUCT WAS UNAVAILABLE. MANUFACTURER NOW ESTIMATES A 10 TO 12 WEEK LEAD TIME.MANUFACTURER NEVER PROVIDED ANY NOTIFICATION OF THE EXTENDED LEAD TIME OR INSTRUCTIONS FOR HOW TO SUBMIT AND TRACK ORDERS SO THAT ORDERS COULD BE PLACED PRIOR TO THE EXPIRATION DATE ON THE PADS. IN FACT VENDOR REPRESENTATIVES STATED VERBALLY THAT WE COULD CONTINUE TO USE THE OUT-OF-DATE PADS.======================MANUFACTURER RESPONSE FOR AED DEFIBRILLATOR, POWERHEART (PER SITE REPORTER).======================AN APPOLOGY FOR THE DELAY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132445 POWERHEART AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION G3 PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *