BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT PADS

    MDR report key: 3850315 · Received March 17, 2014

    Report

    Report Number
    1220908-2014-00629
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 22, 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 AN (B)(6) MALE PT, THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. COMPLAINANT DID NOT INDICATE THAT THERE WAS NAY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157295 CPR STAT PADS ELECTRODES MLN ZOLL MEDICAL CORPORATION 3900-0402 0214

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR