BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 621583 · Received July 18, 2005

    Report

    Report Number
    9610483-2005-00023
    Event Type
    Other
    Date Received
    July 18, 2005
    Date of Event
    December 29, 2003
    Report Date
    January 10, 2004
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN INCIDENT IN 2003 INVOLVING A PATIENT SUFFERING FROM CHEST PAINS AND BEING MONITORED WITH R2 MONITORING PADS, THIS UNIT DISPLAYED QRST THAT APPEARED TO BE UPSIDE DOWN. THINKING THE PADS WERE ON THE PATIENT WRONG, NEW PADS WERE PLACED IN REVERSE OF THE FIRST PADS AND STILL THE QRST DISPLAY LOOKED UPSIDE DOWN. THE INCIDENT PRINTOUT ALSO DISPLAYED THE QRST UPSIDE DOWN. THE PATIENT WAS TRANSPORTED WITHOUT INCIDENT. THE REPORTER FEELS THIS WAS NOT A CARDIAC SITUATION. USE OF THE DEFIB FOR CHEST PAINS IS PER THEIR PROTOCOL. DURING LATER TESTS, THE ECG WAS RIGHT SIDE UP BUT IT LOOKED LARGER THAN NORMAL. THE CUSTOMER SAID THAT THEIR REGULAR R2 CABLE WAS LEFT AT THE HOSPITAL AND THE ONE THEY GOT BACK WAS NOT THE INCIDENT CABLE. THE CUSTOMER INFORMED LAERDAL OF THE ABOVE INCIDENT WHEN THEY CALLED TO PURCHASE A NEW LAERDAL HS3000 CABLE 920601 AND HAVE IT INSTALLED ON THEIR DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SARD LDD LAERDAL MEDICAL A/S HS3000QR 9609

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other