BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1400 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1062140 · Received June 13, 2008

    Report

    Report Number
    1220908-2008-01321
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PD1400 POWER SUPPLY BOARD WAS RETURNED. THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY CAPACITOR ON THE POWER SUPPLY BOARD. A REPLACEMENT BOARD WAS SENT TO THE CUSTOMER. ANALYSIS OF FAILURES OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE WOULD NOT POWER ON. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN 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 NA