BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3781028 · Received April 30, 2014

    Report

    Report Number
    3015876-2014-00473
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    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). THE BIOMEDICAL ENGINEER ADVISED PHYSIO-CONTROL THAT THERE WAS SOME DAMAGE TO THE HARD-PADDLES ASSEMBLY, BUT HE COULD NOT BE CERTAIN WHEN OR HOW THE DAMAGE OCCURRED, OR IF IT CONTRIBUTED TO THE PADDLE PLATES DETACHING FROM THE ASSEMBLY. PHYSIO THEN PROVIDED THE CUSTOMER WITH THE PART NUMBER FOR A REPLACEMENT HARD-PADDLES ASSEMBLY. IT WAS LATER CONFIRMED BY THE BIOMEDICAL ENGINEER THAT HE HAD RECEIVED THE REPLACEMENT HARD-PADDLES ASSEMBLY AND AFTER OBSERVING PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE HARD-PADDLES WERE PLACED INTO SERVICE FOR USE. THE ORIGINAL HARD-PADDLES WERE DISPOSED OF BY THE BIOMEDICAL ENGINEER LOCALLY; THEREFORE THEY WERE NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT THE PADDLE PLATES ON A SET OF THEIR HARD-PADDLES ASSEMBLY HAD DETACHED FROM THE ASSEMBLY. AS A RESULT, THE HARD-PADDLES COULD NOT BE USED FOR DEFIBRILLATION, IF NECESSARY. THE HARD-PADDLES WERE USED IN CONJUNCTION WITH A LIFEPAK 20 DEFIBRILLATOR/MONITOR DEVICE; HOWEVER, THE BIOMEDICAL ENGINEER WAS UNABLE TO PROVIDE THE SERIAL NUMBER FOR THE DEVICE THAT THE PADDLES HAD BEEN INSTALLED ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259925 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20 23621

    Patients

    Seq Age Sex Outcome Treatment
    1