BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 774164 · Received August 23, 2006

    Report

    Report Number
    9610483-2006-00183
    Event Type
    Other
    Date Received
    August 23, 2006
    Date of Event
    April 2, 1999
    Report Date
    April 5, 1999
    Manufacturer
    LAERDAL MEDICAL, A.S.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED WITH THE RETURNED MCM INSTALLED AND THE COMPLAINT OF "ERROR 3 - POSSIBLE MCM OR BUS FAULT" MESSAGE WAS VERIFIED. TESTING WITHOUT THE RETURNED MCM VERIFIED PROPER OPERATION OF THE DEFIBRILLATOR FOR PATIENT TREATMENT. THIS TESTING VERIFIED THE UNIT'S RHYTHM DETECTION CIRCUIT AND ABILITY TO TREAT RHYTHM. THE MCM WAS FOUND TO HAVE A PROM AJAR IN IT'S SOCKET ON THE CIRCUIT BOARD THAT CAUSED THE ERROR MESSAGE AND DISABLED THE DEFIBRILLATOR. THE PROM WAS PROPERLY INSTALLED IN IT'S SOCKET AND PROPER OPERATION OF THE MCM WAS VERIFIED. AT THE SCENE, THE UNIT PERFORMED APPROPRIATELY TO ANALYZE THE PATIENT AS "NO SHOCK INDICATED" 3 TIMES AND IT APPEARS THE PROM BECAME AJAR DURING USE AT THE SCENE OR THE MCM MAY NOT HAVE BEEN INSTALLED IN THE UNIT AT THE START OF TREATMENT. USE OF THE MCM IS EXPLAINED IN THE HS3000 OPERATING INSTRUCTIONS AND INSTRUCTIONS STATE THAT THE HS3000 WILL OPERATE IN SEMI-AUTOMATIC MODE WITHOUT THE MCM. ALSO, IT INCLUDES IN THE RECOMMENDED INSPECTION VERIFYING THAT THERE IS NO MCM MESSAGE PROMPTING AND EXPLAINS WHAT TO DO SHOULD PROBLEMS BE NOTED DURING THE INSPECTION. THIS IS AN UNUSUAL EVENT AND THE USER WAS NOTIFIED OF THE PROBLEM. THE CUSTOMER WAS SENT A LETTER EXPLAINING OUR EVALUATION.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 1999, AT DOCTOR'S OFFICE INVOLVING AN UNCONSCIOUS FEMALE PATIENT WITH CPR BEING PERFORMED BY A DOCTOR, THIS DEFIBRILLATOR ANALYZED THE PATIENT 3 TIMES AS "NO SHOCK INDICATED" BUT AFTER 1 MINUTE OF CPR, THE DEFIBRILLATOR WOULD NOT ANALYZE AND GAVE THE ERROR MESSAGE "ERROR 3 MCM OR BUS FAULT." PARAMEDICS TOOK OVER PATIENT CARE WITH THEIR OWN DEFIBRILLATOR AND THE PATIENT WAS TRANSPORTED TO A HOSPITAL. THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED MKJ LAERDAL MEDICAL, A.S. HS3000ATS 9607

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other