BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 745858 · Received June 7, 2005

    Report

    Report Number
    2132572-2005-00004
    Event Type
    Other
    Date Received
    June 7, 2005
    Date of Event
    May 16, 2005
    Report Date
    June 6, 2005
    Manufacturer
    CARDIAC SCIENCE, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AED WAS FOUND TO BE WITHIN SPECIFICATION. THE BATTERY WAS CONFIRMED TO BE DEPLETED AND IN A LOW ENERGY STATE. AS A RESULT, THE AED WAS NOT "RESCUE READY" DUE TO THE USE OF A DEPLETED BATTERY.

    Description of Event or Problem · 1

    DURING AN ATTEMPTED RESCUE OF A SUSPECTED CARDIAC ARREST VICTIM, AFTER THE PADS WERE PLACED ON THE PATIENT, THE AED LOST ITS POWER AND SHUT DOWN AND ACCORDINGLY, THE DEVICE DID NOT DELIVER A SHOCK WHEN THE SHOCK BUTTON WAS PUSHED. THE AED AND THE BATTERY WERE SUBSEQUENTLY RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF THE EVENT LOG IN THE AED INDICATED THAT THE AED ISSUED A BATTERY LOW WARNING FOR SEVERAL DAYS IN DECEMBER 2004 AT WHICH TIME THE EVENT LOG RECORDED THAT THE BATTERY WAS REMOVED FROM THE AED. THE NEXT ENTRY IN THE AED EVENT LOG INDICATED THAT THE BATTERY WAS INSTALLED IN THE AED JUST PRIOR TO THE RESCUE ATTEMPT AND THE EVENT LOG RECORDED THE SAME BATTERY LOW WARNING. THE AED WAS NOT FUNCTIONAL DUE TO THE USE OF A DEPLETED BATTERY. THE AED RECORDED THAT THE DEVICE HAD NOT BEEN IN SERVICE FOR MANY MONTHS AND THE EVENT LOG INDICATES THAT THE AED WAS NOT MADE RESCUE-READY IN ADVANCE OF THE RESCUE ATTEMPT. IT WAS REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FASTSAVED AED MKJ CARDIAC SCIENCE, INC. 9210-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other