BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD1200 DEFIBRILLATOR/PACEMAKER

    MDR report key: 216836 · Received March 31, 1999

    Report

    Report Number
    1220908-1999-00245
    Event Type
    Death
    Date Received
    March 31, 1999
    Date of Event
    March 4, 1999
    Report Date
    March 4, 1999
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE CLINICIANS WERE ATTEMPTING TO DEFIBRILLATE A TEEN-AGE FEMALE PT (EXACT AGE UNK) IN CARDIAC ARREST WITH THE DEVICE PLUGGED INTO AC POWER, BUT THE UNIT POWERED DOWN WITHOUT WARNING. THE CLINICIANS WERE ABLE TO OBTAIN ANOTHER DEVICE TO TREAT THE PT. THE COMPLAINANT INDICATED THAT THE PT OUTCOME WAS NOT AS A RESULT OF THE REPORTED MALFUNCTION. THE COMPLAINANT INDICATED THAT TWO PRIOR UNREPORTED EVENTS OCCURRED WITH THIS DEVICE. THOSE EVENTS ARE REPORTED ON MEDWATCH REPORTS 1220908-1999-00246 AND 1220908-1999-00247. IT WAS UNK IF THOSE PRIOR MALFUNCTIONS OCCURRED WHILE IN USE ON A PT. PT'S AGE AT TIME OF EVENT WAS REPORTED TO BE TEENAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD1200 DEFIBRILLATOR/PACEMAKER DEFIBRILLATOR LDD ZOLL MEDICAL CORP. PD1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death