BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM EST 18FR 400 SERIES 100CS

    MDR report key: 4359855 · Received December 12, 2014

    Report

    Report Number
    9613793-2014-00010
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 3, 2014
    Report Date
    December 12, 2014
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBLA PARK
    Product Code
    BZT
    PMA / PMN Number
    K925789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WILL PROVIDE FOLLOW UPS IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    TEMPERATURE PROBES ARE NOT READING PROPERLY. ESOPHAGEAL STETHOSCOPES. VITAL TEMP 18FR REF 1011EU LOT 9475716. THE FIRST FAILURE OCCURRED WHEN I PLACED THE ES, THEN HOOKED UP THE MONITOR LEAD AND GOT DOUBLE DASHES, I.E. NO READING. I DID SOME TROUBLESHOOTING THAT INDICATED THAT THE LEAD WIRE AND THE MONITOR WERE OK. I DECIDED IT MUST HAVE BEEN AN ISOLATED DEFECT, BECAUSE I HADN'T SEEN IT BEFORE, BUT DECIDED TO CHECK THE PROBES AT ROOM TEMPERATURE PRIOR TO INSERTING WHAT MIGHT BE A USELESS MONITOR INTO SOMEONE'S ESOPHAGUS. THERE'S A SMALL BUT NON-ZERO RISK OF COMPLICATIONS FROM INSERTING EVEN A FUNCTIONING ES INTO A PATIENT. I OPENED THIS PACKAGE AND TESTED THE PROBE. IT READ ROOM TEMPERATURE CORRECTLY, SO I INSERTED THE ES INTO MY PATIENT. AT FIRST, THE PROBE GAVE CREDIBLE READINGS IN THE 35-367 C RANGE. SUDDENLY THE TEMPERATURE BEGAN TO VACILLATE ALL OVER THE PLACE, READING ANYWHERE FROM 19 TO 36 C. THIS WAS NOT ASSOCIATED WITH CAUTERY OR ANY OTHER "NORMAL" SOURCE OF INTERFERENCE. I CANNOT RULE OUT PENETRATION OF THE LIQUID-PROOF BARRIER TO THE ES AT THIS TIME, WHICH MIGHT EXPOSE THE PATIENT TO STRAY CURRENTS INDUCED IN THE LEAD WIRE OR A SPURIOUS PATH TO GROUND IN THE CAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815437 OEM EST 18FR 400 SERIES 100CS STETHOSCOPE, ESOPHAGEAL, WITH ELECTR BZT DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBLA PARK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention