BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPR STAT PADS

    MDR report key: 3850314 · Received March 17, 2014

    Report

    Report Number
    1220908-2014-00628
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Report Date
    February 26, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 ATTEMPTING TO DEFIBRILLATE A (B)(6) FEMALE PT, THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. 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
    157347 SPR STAT PADS ELECTRODES MLN ZOLL MEDICAL CORPORATION 8900-0402 5012

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR