BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3820217 · Received May 20, 2014

    Report

    Report Number
    3015876-2014-00562
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS BEEN UNABLE TO REACH THE CUSTOMER REGARDING THE RESOLUTION OF THE REPORTED ISSUE. SEVERAL UNSUCCESSFUL CONTACT ATTEMPTS HAVE BEEN MADE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED DEVICE ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SHOCK BUTTON WAS MISSING FROM THEIR DEFIBRILLATION HARD PADDLES ASSEMBLY. WITHOUT THE SHOCK BUTTON ON THE HARD PADDLES ASSEMBLY, THE DEVICE WOULD NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY WHILE USING THE HARD PADDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299966 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1