BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR (AA) ELECTRODES

    MDR report key: 2678877 · Received July 25, 2012

    Report

    Report Number
    1220908-2012-01846
    Event Type
    Malfunction
    Date Received
    July 25, 2012
    Report Date
    July 5, 2012
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO APPLY THE ELECTRODE PADS TO A PT THE WIRE WAS LOOSE. COMPLAINANT INDICATED THAT THEY OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH 122098-2012-01845 FOR THE SECOND SET OF PADS USED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONESTEP CPR (AA) ELECTRODES ELECTRODE MKJ ZOLL MEDICAL CORP 8900-0217-01 0312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK