BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 729056 · Received June 26, 2006

    Report

    Report Number
    9610483-2006-00128
    Event Type
    Other
    Date Received
    June 26, 2006
    Report Date
    December 21, 2000
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    MKJ
    PMA / PMN Number
    K896919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED USING A KNOWN GOOD POWER SOURCE AND PROPER OPERATION FOR PATIENT TREATMENT WAS VERIFIED. THIS TESTING VERIFIED THE UNIT'S RHYTHM DETECTION CIRCUIT AND ABILITY TO TREAT A RHYTHM. THE RETURNED MCM DID NOT CONTAIN INCIDENT INFORMATION. ONE OF THE 2 RETURNED BATTERIES, LAERDAL EXPIRED LOT 970702, DELIVERED AT LEAST 15 360J SHOCKS BEFORE PROMPTING "BATTERY LOW". THE NON-LAERDAL BATTERY, NO LOT #, DELIVERED 2 SHOCKS BEFORE PROMPTING "BATTERY LOW" AND WOULD NOT PASS THE BATTERY CAPACITY TEST DEFINED IN THE HS3000 OPERATING INSTRUCTIONS.

    Description of Event or Problem · 1

    THERE IS NO PT REPORT AVAILABLE. THE INCIDENT DATE IS UNK. THE FIRE DEPARTMENT RETURNED THIS DEFIBRILLATOR TO THE EQUIPMENT SERVICE FACILITY WITH A VERBAL REPORT THAT THERE WAS A PT INVOLVED AND THE UNIT DID NOT SHOCK. AN ALS CREW TOOK OVER PT CARE. DIRECTOR OF THE FIRE DEPARTMENT/EMS MEDICAL EQUIPMENT UNIT, TRIED TO OBTAIN THE REQUIRED INFORMATION FROM THE FIRE DEPARTMENT BUT DOESN'T BELIEVE THERE IS ANY ADDITIONAL INFORMATION. IT IS AN ON-GOING BATTLE WITH THE FIRE DEPARTMENT TO GET IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A.S. HS3000 9603

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other