BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 3891768 · Received February 8, 2014

    Report

    Report Number
    1220908-2014-00295
    Event Type
    Malfunction
    Date Received
    February 8, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 21, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNK) FOR CARDIAC ARREST, THE DEVICE FAILED TO PACE THE PATIENT. CLINICIANS INDICATED THAT THE PATIENT WAS TRANSFERRED FROM ANOTHER DEPARTMENT AND THE CARDIAC ARREST NURSE DID NOT CHANGE THE PADS AND ONLY ATTEMPTED TO CHANGE DEVICES; HOWEVER, THE PADS FROM THE PREVIOUS DEVICE WOULD NOT CONNECT TO THE NEW DEVICE AND THE PADS HAD TO BE CHANGED TO CONNECT THE PATIENT TO THE DEFIBRILLATOR. THE PATIENT'S PULSE WAS WEAK AND THE PADS WERE CHANGED RESULTING IN ADEQUATE PACING OF THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86443 R SERIES DEFIBRILLATOR DEFIBRILLATOR/ PACEMAKER MKJ ZOLL MEDICAL CORPORATION R SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK