BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1400 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1190690 · Received October 3, 2008

    Report

    Report Number
    1220908-2008-02258
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    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 CARDIOVERT THE HEART RHYTHM OF A PATIENT THE DEVICE DISPLAYED A "STATUS 90" ERROR MESSAGE. THE CLINICIAN REPLACED THE BATTERY AND CONTINUED TO TREAT THE PATIENT SUCCESSFULLY, WITH THIS DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. SUBSEQUENT BIOMED TESTING WITH THE EVENT BATTERY, WAS NOT ABLE TO DUPLICATE THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD1400 DEFIBRILLATOR/PACEMAKER DEFIBRILLATOR LDD ZOLL MEDICAL CORPORATION PD1400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK