BEUDAMED
    FDA Adverse Event Other Summary report: N

    5400 Q-TRACE 100P 100B 4000C

    MDR report key: 3766817 · Received April 10, 2014

    Report

    Report Number
    1219103-2014-00010
    Event Type
    Other
    Date Received
    April 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTRODE. THE CUSTOMER REPORTS THAT THE ELECTRODES DO NOT STICK AS WELL AS THEY SHOULD. THEY WORK REASONABLY WELL IF THE PT HAS REGULAR SKIN. IF THE PT HAS THE LEAST BIT OF LOTION, PERSPIRATION, BODY HAIR, OR DRY SKIN, THE ELECTRODES DO NOT FUNCTION WELL. WE HAD A PT WHO HAD A HEART RATE OF 200. THE PHYSICIAN AND NURSES WERE GOING TO INJECT A CERTAIN DRUG INTO THE IV TO SLOW THE HEART RATE. THE PURPOSE OF THE CARDIOLOGY TECHNOLOGIST IS TO CAPTURE THE MOMENT THE DECREASE HAPPENS. THE CUSTOMER WAS RECORDING THE TRACING AND EXACTLY AT THE CRUCIAL MOMENT WHEN THE HEART RATE DECREASED, THE ELECTRODE FELL OFF AND THE CAPTURE WAS MISSED. THE PHYSICIAN ASKED IF THE CAPTURE RECORDED PROPERLY AND IT DID NOT. THE CUSTOMER FURTHER REPORTS THAT THE PROCEDURE IS A DRUG INJECTION OF ADENOSINE TO SLOW THE HEART RATE. THE PROCEDURE IS DONE QUICKLY. ONCE THE DRUG IS INJECTED INTO THE PT, IT IS SHORT ACTING. THE CONVERSION HAPPENS QUICKLY. THE CUSTOMER HAD CONNECTED THE PT TO THE ECG AND HAD RECORDED AN INITIAL TRACING. THEY HAD THE MACHINE SET TO RECORD A RHYTHM STRIP CONTINUOUSLY HOPING TO CAPTURE THE EXACT MOMENT THE DRUG TAKES EFFECT AND THE HEART RATE CHANGES. THE DRUG HAD BEEN INJECTED AND THEY WERE JUST WAITING FOR THE CONVERSION WHEN THE ELECTRODE FELL OFF. THE STAFF WAS UNABLE TO REPEAT THE PROCEDURE. THIS WAS AN EMERGENCY PROCEDURE TO GET THE PT'S HEART RATE DOWN TO NORMAL. SKIN WAS PREPPED PROPERLY. IF THE HEART BEAT DROP WAS CAUGHT THE NEXT ACTION WOULD BE TO RECORD THE DRUG AND THE AMOUNT THAT WAS USED TO CONVERT. IF THE DOCTOR COULD NOT CAPTURE THE HEART BEAT AT THIS CRITICAL MOMENT THEN NOTHING WOULD CHANGE IN THE TREATMENT FOR THE PT. IF THE HEART RATE CONVERTED THEY WOULD NOT HAVE RECORD AND IF IT DID NOT CONVERT THEY WOULD GO TO A HIGHER DOSE OR DIFFERENT MEDICATION. THE CUSTOMER REPORTS THAT THE WORST CASE OUTCOME WOULD BE THAT NO RECORD OF THE CONVERSION WAS OBTAINED AND NO RHYTHM STRIP AVAILABLE SHOULD THE PT BE ADMITTED AGAIN. WITH THIS DRUG IT IS CRUCIAL TO CATCH THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217185 5400 Q-TRACE 100P 100B 4000C ELECTRODE DRX COVIDIEN 31433538 321405X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other