BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5180020

    MDR report key: 5180020 · Received October 27, 2015

    Report

    Report Number
    5180020
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    July 15, 2015
    Report Date
    September 23, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    WHILE AT PATIENT'S RESIDENCE EVALUATING HER FOR CHEST, BACK AND ABDOMINAL PAIN, EKG ELECTRODES FAILED TO REGISTER A RHYTHM ON MONITOR EVEN AFTER MULTIPLE ATTEMPTS AND NEW ELECTRODES REPLACED MULTIPLE TIMES. FINALLY AFTER 10 MINUTES FROM INITIAL PATIENT CONTACT, RAN BACK TO AMBULANCE AND OPEN SEALED CABINET AND FOUND 3M RED DOT ELECTRODES AS LAST ATTEMPT TO GET AN EKG BEFORE CALLING LEAD MEDIC AND MONITOR REGISTERED; BEGAN ASSESSMENT AS SOON AS THEY WERE PLACED ON PT. ELECTRODES WERE LEFT WITH LEAD MEDIC AND A SPECIAL REPORT ALSO FILED.

    Description of Event or Problem · 1

    WHILE AT PATIENT'S RESIDENCE EVALUATING HER FOR CHEST, BACK AND ABDOMINAL PAIN, COVIDIEN (B)(6) EKG ELECTRODES FAILED TO REGISTER A RHYTHM ON MONITOR EVEN AFTER MULTIPLE ATTEMPTS AND NEW ELECTRODES REPLACED MULTIPLE TIMES. FINALLY AFTER 10 MINUTES FROM INITIAL PATIENT CONTACT, RAN BACK TO AMBULANCE AND OPEN SEALED CABINET AND FOUND 3M RED DOT ELECTRODES AS LAST ATTEMPT TO GET AN EKG BEFORE CALLING LEAD MEDIC AND MONITOR REGISTERED; BEGAN ASSESSMENT AS SOON AS THEY WERE PLACED ON PT. ELECTRODES WERE LEFT WITH LEAD MEDIC AND A SPECIAL REPORT ALSO FILED.

    Patients

    Seq Age Sex Outcome Treatment
    1