BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 9 DEFIBRILLATOR/MONITOR

    MDR report key: 3200241 · Received July 1, 2013

    Report

    Report Number
    3015876-2013-00564
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL CONFIRMED WITH THE CUSTOMER THAT THEY HAVE REMOVED THE DEVICE FROM SERVICE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT CHARGE AND DEFIBRILLATE BEYOND 20 JOULES AND, AS A RESULT, WAS UNABLE TO DELIVER SUFFICIENT DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298238 LIFEPAK(R) 9 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 9

    Patients

    Seq Age Sex Outcome Treatment
    1