BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, MFE, STAT-PADZ II

    MDR report key: 1470199 · Received July 29, 2009

    Report

    Report Number
    1220908-2009-01904
    Event Type
    Malfunction
    Date Received
    July 29, 2009
    Report Date
    July 14, 2009
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 TREAT A PT, THE ELECTRODE PACKAGING WAS OPENED AND THE PACKAGING REMAINED ON THE ELECTRODE ADHESIVE AND THE ELECTRODE WAS UNABLE TO ADHERE TO THE PT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODES, MFE, STAT-PADZ II DEFIB MEDICAL CORP MLN ZOLL MEDICAL CORPORATION 8900-0801 3907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK