BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 889122 · Received September 22, 2006

    Report

    Report Number
    9610483-2006-00226
    Event Type
    Other
    Date Received
    September 22, 2006
    Date of Event
    June 5, 2000
    Report Date
    January 31, 2001
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    MKJ
    PMA / PMN Number
    k896919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED AND THE REPORTED PROMPT OF "NEEDS SCV, ENERGY LOW" WAS VERIFIED. A TRANSFER RELAY, K2 ON THE HIGH VOLTAGE BOARD WAS FOUND DEFECTIVE (REPORTED, AFTER EVAL BY THE RELAY MFR, TO BE A SOLDER PROBLEM). K2 AND ITS PAIR K3 WERE REPLACED AND PROPER OPERATION FOR PT TREATMENT WAS VERIFIED. THE HS3000 OPERATING INSTRUCTIONS EXPLAIN THAT THE HS3000 MONITORS CAPACITOR ENERGY BEFORE AND IMMEDIATELY AFTER A SHOCK. THE MESSAGES "ENERGY HIGH" OR "ENERGY LOW" OCCUR AT VARIANCES OF MORE THAN +/- 20% FROM DELIVERED ENERGY AS SELECTED. THE INSTRUCTIONS ALSO EXPLAIN WHAT TO DO, SHOULD THESE MESSAGES BE EXPERIENCED. LAERDAL MEDICAL REPORTS THAT THIS IS A MECHANICAL ERROR OF LOW ERROR FREQUENCY FOR A MECHANICAL COMPONENT AND NO CORRECTIVE ACTION IS NECESSARY. A PREVIOUS EVAL OF THIS SAME UNIT FOR "CHECK ELECTRODES" PROMPT FOUND A CORRODED CABLE CONNECTION TO BE CAUSING THE INTERMITTENT PT CONTACT PROBLEM. LAERDAL MEDICAL BELIEVES, AFTER THIS REPORT OF "NEEDS SVC, ENERGY LOW" AND NO ENERGY OUT TO THE PT, THAT THE PREVIOUS CONDITION OF "CHECK ELECTRODES" REPORTED ON MDR # 9610483-2006-00229 COULD ALSO HAVE BEEN CAUSED BY THIS K2 FAILURE. LAERDAL MEDICAL HAS REPORTED THIS INCIDENT TO AUTHORITIES.

    Description of Event or Problem · 1

    DURING AN INCIDENT, IN A FOREIGN COUNTRY, IN 2000, INVOLVING AN UNK PT IN CARDIAC ARREST, THIS DEFIBRILLATOR CHARGED UP AS NORMAL AND AFTER SHOCKING DISPLAYED 1 SHOCK WAS DELIVERED, BUT NO SHOCK WAS GIVEN TO THE PT. THE UNIT ALSO DISPLAYED "LOW ENERGY". THE BATTERY WAS REPLACED WITH A FULLY CHARGED BATTERY, BUT THIS DID NOT HELP. BOTH BATTERIES HAD BEEN CHARGED PER PROCEDURE. ANOTHER DEFIBRILLATOR WAS USED AND SHOCK WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL A/S HS3000 9605

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other