BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1011943 · Received March 11, 2008

    Report

    Report Number
    3015876-2008-00161
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL DEPARTMENT EVALUATED THE DEVICE AND ACCESSORIES AND OBSERVED THAT ONE OF THE TWO CABLES FROM THE INTERNAL HANDLES WAS ELECTRICALLY OPEN. PHYSIO-CONTROL PROVIDED CUSTOMER PART NUMBER AND PRICE TO REPLACE ACCESSORY.

    Description of Event or Problem · 1

    FOUND DURING TESTING BEFORE USE ON PATIENT. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT DELIVER ENERGY THROUGH THE INTERNAL PADDLES CONNECTED TO THE DEVICE. ANOTHER DEVICE WAS CALLED FOR AND USED AND NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THE DEVICE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DEFIBRILLATION ADAPTER FOR THE LIFEPAK 9P| P/N 803747| INTERNAL HANDLES AND CABLES FOR LIFEPAK 9P| P/N 800441