BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 6115660 · Received November 19, 2016

    Report

    Report Number
    1218058-2016-00145
    Event Type
    Malfunction
    Date Received
    November 19, 2016
    Date of Event
    October 26, 2016
    Report Date
    November 1, 2016
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE ELECTRODE PADS AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE RETURNED ELECTRODES AND THE CUSTOMER?S REPORT WAS NOT OBSERVED VISUALLY OR FUNCTIONALLY. RETAIN SAMPLES WERE EVALUATED AND DETERMINED TO BE ASSEMBLED PROPERLY AND MEET ZOLL SPECIFICATION. WE TRIED TO CONTACT THE CUSTOMER TO UNDERSTAND IF THE SELF-TEST CONNECTION PLAYED A ROLE IN THE REPORT, BUT WE WERE UNSUCCESSFUL IN OUR ATTEMPT. REPLACEMENT ELECTRODE PADS WERE SENT TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE WIRES TO THE ELECTRODES WERE NOT ATTACHED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766573 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0224-01 3316A

    Patients

    Seq Age Sex Outcome Treatment
    1