BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRP STAT PADZ

    MDR report key: 1279710 · Received December 29, 2008

    Report

    Report Number
    1220908-2008-03129
    Event Type
    Malfunction
    Date Received
    December 29, 2008
    Report Date
    December 16, 2008
    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

    THE CUSTOMER HAS INDICATED THAT THE ELECTRODE PADS HAVE BEEN DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. ANALYSIS OF FAILURES OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE PERFORMING CPR COMPRESSIONS ONTO A PATIENT, THE ELECTRODES PADS SEEMED TO BE LIFTING AS A RESULT OF THE CPR PUCK. THE ATTENDING CLINICIAN HELD THE ELECTRODES PADS TO THE PATIENT'S CHEST TO KEEP THEM ON. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. THE CUSTOMER HAS INDICATED THAT THE ELECTRODE PADS HAVE BEEN DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION. THE CUSTOMER HAS INDICATED THAT THEY HAVE HAD SEVERAL INCIDENTS WHICH WERE NOT REPORTED TO ZOLL IN THE PAST. PLEASE REFENCE OTHER REPORTS OF THIS NATURE FILED BY THIS CUSTOMER, ON MEDWATCH REPORT NUMBERS: 1220908-2008-03102, 1220908-2008-03103, 1220908-2008-03104, 122908-2008-03130, 1220908-2008-03133, 1220908-2008-03134, AND 1220908-2008-03135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRP STAT PADZ ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK