BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PADS ELECTRODES

    MDR report key: 3850312 · Received March 17, 2014

    Report

    Report Number
    1220908-2014-00722
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A (B)(6), MALE PT, AN ARC WAS HEARD FROM THE ELECTRODE PADS. COMPLAINANT DID NOT INDICATE AN ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157294 STAT PADS ELECTRODES ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-4003 4513

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR