BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHYSIO CONTROL

    MDR report key: 110721 · Received July 31, 1997

    Report

    Report Number
    MW1011822
    Event Type
    Other
    Date Received
    July 31, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 28, 1997
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR FAILED TO FIRE DURING RESUSCITATION EFFORTS. ANOTHER UNIT WAS IMMEDIATELY AVAILABLE AND FUNCTIONED NORMALLY BUT RESUSCITATION WAS UNSUCCESSFUL. CLINICAL STAFF AT EVENT DETERMINED THAT FAILURE OF 1ST UNIT DID NOT CONTRIBUTE TO PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL DEFIBRILLATOR/PACER/MONITOR LDD PHYSIO CONTROL LIFEPAK 9P *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other