BEUDAMED
    FDA Adverse Event Other Summary report: N

    90088740 NIHON KOHDEN TELE 6 LD

    MDR report key: 3536482 · Received December 13, 2013

    Report

    Report Number
    1282497-2013-00055
    Event Type
    Other
    Date Received
    December 13, 2013
    Report Date
    December 6, 2013
    Manufacturer
    LHI TECHNOLOGY
    Product Code
    DSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A LEAD SET. THE CUSTOMER STATES THAT THERE ARE CONNECTIVITY ISSUES INCLUDING LACK OF TRACINGS, LOSS OF TRACINGS, AND DRAMATIC/SHARP TRACINGS WHEN KDL ITEM # 33134 IS IN USE. THE CUSTOMER STATES THAT THERE HAS BEEN NO CHANGE IN PRACTICE OR PROTOCOL WITH CARDIAC MONITORING. THE CUSTOMER CONNECTS THE KDL TO A NIHON KOHDEN REUSABLE TRUNK CABLE, ITEM # JC906PA. THE TRUNK CABLE IS CONNECTED INTO A NIHON KOHDEN MONITOR. THE CUSTOMER HAS TWO TYPES OF MONITORS IN THE DEPARTMENT, NIHON KOHDEN # MU671RA AND NIHON KOHDEN # 5106A. THE CONNECTIVITY ISSUE HAS OCCURRED IN MULTIPLE AREAS OF THE 32-BED DEPARTMENT. THE CUSTOMER FURTHER STATES THAT THE KDL 33134 LEADSET WAS IN USE ON A PT THAT WAS CODING AND THE PT EXPIRED. DURING THAT TIME, THE LEADSET WAS NOT SHOWING A TRACING; HOWEVER, THEY WERE GETTING TRACINGS FROM THE DEFIBRILLATOR THAT WAS ALSO CONNECTED. THE CUSTOMER REPORTS THAT THE NURSE MANAGER STATED THAT OUR LEADSET WAS NOT THE CAUSE OF THE PTS DEATH. THERE WERE OTHER COMPLICATIONS THAT LED TO THE EVENT; HOWEVER, THEY NOTED THAT THERE WAS NO TRACE FROM OUR LEADSET DURING THE TIME OF THE INCIDENT, SO THEY HAD TO CHECK FOR CARDIAC RHYTHM ON A DEFIBRILLATOR THAT WAS ALSO IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654054 90088740 NIHON KOHDEN TELE 6 LD LEADSET DSA LHI TECHNOLOGY 33134 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other