BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAR PADZ

    MDR report key: 3851218 · Received March 25, 2014

    Report

    Report Number
    1220908-2014-00726
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PARAMEDIC

    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 PERFORMING COMPRESSIONS ON A (B)(6) OLD, FEMALE PT, THE CORNERS OF THE ELECTRODE PADS BEGAN TO LIFT AND LOSE ADHESION 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
    173843 CPR STAR PADZ ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0400 4013

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR