BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1400 DEFIBRILLATOR/PACEMAKER

    MDR report key: 872804 · Received June 26, 2007

    Report

    Report Number
    1220908-2007-01380
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DURING BIOMED TESTING, THE DEVICE HAD NO ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PT 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 YR