BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 803868 · Received June 14, 2006

    Report

    Report Number
    9610483-2006-00110
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    March 8, 2000
    Report Date
    September 11, 2000
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEFIBRILLATOR WAS TESTED AND FOUND ABLE TO ASSESS AND CHARGE, BUT DID NOT PROMPT "SHOCK DELIVERED," IT SHUT DOWN WITH THE "ALERT" LAMP ILLUMINATED. THE UNIT'S UPPER BOARD WAS FOUND TO HAVE A CHARGE-TIME CIRCUIT PROBLEM. THE UPPER BOARD WAS REPLACED AND PROPER OPERATION OF THE DEVICE FOR PATIENT TREATMENT WAS VERIFIED. THE UPPER BOARD WAS FURTHER EVALUATED TO FIND IT OPERATED PROPERLY FOR PATIENT TREATMENT; NO PROBLEMS WERE FOUND. WE BELIEVE, DUE TO THE REPORT OF PEA AT THE SCENE AFTER THE USE OF THIS AUTOMATIC DEFIBRILLATOR THAT THE DEFIBRILLATOR DID NOT FIND THE PATIENT TREATABLE, AND THEREFORE DID NOT DELIVER SHOCK. IT IS NOT LIKELY THE INTERMITTENT "ALERT" CONDITION FOUND 6 MONTHS LATER DURING THIS SERVICE WAS PRESENT AT THE SCENE BECAUSE IT WAS NOT MENTIONED BY THE CUSTOMER DURING THEIR REPORT OF THIS PROBLEM. IT WAS REPORTED THE DEVICE "JUST KEPT ASSESSING ON AND ON." NO CHARGE CYCLE WAS REPORTED SO THAT NO CHARGE-TIME ERROR WOULD HAVE BEEN INVOLVED. THE HS1000 OPERATING INSTRUCTIONS EXPLAIN THAT: "THIS RED ALERT INDICATOR LIGHTS IF AN INTERNAL DEVICE FAULT HAS BEEN DETECTED. IN THIS EVENT, THE DEVICE WILL COMPLETELY SHUT DOWN, WITH ONLY THE ALERT INDICATOR REMAINING ON." IT EXPLAINS WHAT TO DO SHOULD THE ALERT INDICATOR BE EXPERIENCED. THIS REPORT IS THE RESULT OF A RETROSPECTIVE COMPLAINT REVIEW BY LMC. IT 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 IN 2000 INVOLVING A MALE PATIENT IN CARDIAC ARREST, THIS DEFIBRILLATOR ASSESSED, BUT WOULD NOT SHOCK. CPR WAS PERFORMED UNTIL PARAMEDICS ARRIVED. THE PARAMEDIC CREW DID NOT SHOCK THE PATIENT WHO THEY FOUND TO BE IN PEA. UPON INITIAL ARRIVAL, THE PATIENT WAS FOUND LYING ON THE FLOOR AND HIS PULSE WAS APNEIC. THE PATIENT WAS PRONOUNCED AT A HOSPITAL. THE CUSTOMER SAID THE DEFIBRILLATOR JUST KEPT ASSESSING ON AND ON WITH NO RESULT, AND THE DEVICE PROBLEM DID NOT AFFECT PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SAED LDD LAERDAL MEDICAL A.S. HS1000 9409

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other