BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR ADAPT CABLE ICP, 5 PIN NIHON-KOHDEN

    MDR report key: 4788677 · Received May 19, 2015

    Report

    Report Number
    8010219-2015-00028
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    December 10, 2012
    Report Date
    December 12, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2015. THE INVESTIGATION INCLUDED. THE CABLE PASSED THE CONTINUITY CHECK TEST ACCORDING TO THE DRAWING SK140919_6, NO FAULT WAS FOUND. THE DHR REVIEW WAS COMPLETED FOR ICP33 NIHON KODEN 5P ADAPTER, CABLE, LOT NUMBER 1140321, SALES ORDER NUMBER (B)(6), AND PURCHASE ORDER NUMBER (B)(6). IT WAS MANUFACTURED CORRECTLY IN ACCORDANCE WITH COMPANY'S PROCEDURES AND STANDARDS. NO RECORDED ANOMALIES HAVE BEEN IDENTIFIED THAT COULD BE ASSOCIATED TO THE COMPLAINT INCIDENT. THE QUANTITY OF COMPLAINTS OVER THE 12 MONTH PERIOD WITH THE KEY WORDS IDENTIFIED IN THE COMPLAINT REVIEW CAN BE CALCULATED AS 0.004% OF PROCEDURES. CONCLUSION: SINCE THE COMPLAINT INCIDENT COULD NOT BE DUPLICATED AND THE ICP33 CABLE WAS VERIFIED AS WORKING TO SPEC, NO ROOT CAUSE CAN BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THERE WAS NO RESISTANCE (39 2K OHMS). INTEGRA SIDE". THERE WAS NO PT CONTACT AND NO PT INJURY. PRODUCT WAS DETACHED BY THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324194 MONITOR ADAPT CABLE ICP, 5 PIN NIHON-KOHDEN NA GWM INTEGRA NEUROSCIENCES, LTD. 1140321

    Patients

    Seq Age Sex Outcome Treatment
    1