BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 728432 · Received June 23, 2006

    Report

    Report Number
    9610483-2006-00123
    Event Type
    Other
    Date Received
    June 23, 2006
    Date of Event
    November 10, 2000
    Report Date
    November 15, 2000
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS TESTED USING A KNOWN GOOD POWER SOURCE AND PROPER OPERATION WAS VERIFIED. THE 2 RETURNED EXPIRED BATTERIES WERE TESTED AS FOLLOWS: THE LAERDAL BATTERY LOT 960913 DELIVERED 4 SHOCKS BEFORE THE UNIT SHUT DOWN PROMPTING "REPLACE BATTERY, BATTERY LOW", AND THE NON-LAERDAL BATTERY LOT 940412 COULD NOT DELIVER EVEN ONE SHOCK BEFORE SUTTING DOWN THE UNIT PROMTING "REPLACED BATTERY, BATTERY LOW." BOTH BATTERIES WOULD FALL THE BATTERY CAPACITY TEST AS DEFINED IN THE HS3000 OPERATING INSTRUCTIONS. THE MESSAGE "REPLACE BATTERY, BATTERY LOW" PROMPTS WHEN THE BATTERY LACKS THE CAPACITY TO PERFORM AS REQUIRED AND THE DEFIBILLATOR SHUTS DOWN. THE INCIDENT REPORT PRINTED FROM THE RETURNED MCM DOCUMENTS 2 CYCLES OF ANALYSIS, START CHARGING, "NO SHOCK INDICATED", AND SHOCK ABORTED. THE UNIT WAS TURNED OFF AND BACK ON AGAIN WITH A "REPLACE BATTERY, BATTERY LOW MESSAGE AND SHUT DOWN. A THIRD POWER-ON RESULTED IN ANOTHER ABORTED CHARGE AND "NO SHOCK INDICATED". PER THE HS3000 OPERATING INSTRUCTIONS, THE "NO SHOCK INDICATED", MESSAGE IS DISPLAYED IN THE SEMI-AUTO MODE WHEN ECG ANALYSIS DOES NOT DETECT A SHOCKABLE RHYTHM AFTER ANALYZE IS ACTIVATED. THIS REPORT IS THE RESULT OF A RETROSPECTIVE COMPLAINT REVIEW BY LMC. IT IS TIMELY FILED UNDER LMC'S REVISED MDR PROCEDURE AND ITS WRITTEN COMMITMENT TO THE AGENCY, EACH OF WHICH HAS RESULTED FROM LAERDAL'S RECEIVING INFORMATION RELATING THE AGENCY'S CURRENT THINKING WITH RESPECT TO MDR REGULATION INTERPRETATION AND ENFORCEMENT POLICY.

    Description of Event or Problem · 1

    DURING AN INCIDENT ON 11/10/00 INVOLVING A FEMALE PT IN CARDIAC ARREST DURING DIALYSIS TREATMENT, THIS DEFIBRILLATOR CHARGED BUT DUMPED THE CHARGE HALFWAY THROUGH 3 TIMES. CPR WAS CONTINUED. THE CREW REPLACED THE BATTERY, BUT THAT ONE WAS DEAD SO THEY REINSTALLED THE FIRST BATTERY AND AGAIN THE UNIT DUMPED THE CHARGE. ALS ARRIVED, BEGAN ALS INTERVENTION, AND TRANSPORTED THE PT TO A HOSPITAL WITH NO CHANGE TO HER CONDITION. THE PT WAS 2 HOURS INTO A 3 HOUR DIALYSIS TREATMENT AND WAS FOUND RECLINED IN A CHAIR NOT BREATHING AND WITHOUT PULSE. THE DIALYSIS CENTER STAFF WAS PERFORMING INADEQUATE CPR.

    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 72 YR Other