BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1070826 · Received July 3, 2008

    Report

    Report Number
    3015876-2008-00747
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 13, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO EVALUATE THE DEVICE AND INVESTIGATE THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT CHARGE WHEN USED ON A PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE DEVICE USE. THE HOSPITAL BIOMEDICAL DEPT EVALUATED THE DEVICE AND OBSERVED PROPER OPERATION. THE FACILITY RETURNED THE DEVICE TO PHYSIO-CONTROL FOR FURTHER EVAL.

    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