BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2896997 · Received January 4, 2013

    Report

    Report Number
    3015876-2013-00014
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS BEEN UNABLE TO REACH THE CUSTOMER REGARDING THE INVESTIGATION OF THE REPORTED FAILURE. 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 REPORTED THAT DURING A PATIENT EVENT IN THEIR CATHETERIZATION LAB, THE ECG SIGNAL WAS INTERMITTENTLY DISAPPEARING WHEN USING THE HARD PADDLES ASSEMBLY ON THE PATIENT. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS REGARDING THE OUTCOME OF THE PATIENT OR THE DETAILS OF THE ACTUAL EVENT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED TO PHYSIO-CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4618 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1