BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR

    MDR report key: 3061625 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01101
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER EVALUATED THE DEVICE AND LOCALIZED THE CAUSE OF THE ISSUE TO A FAILURE OF THE INTERNAL PADDLE SET. HE NOTED THAT THE PADDLE SET WAS VERY WORN. THE CUSTOMER ORDERED A REPLACEMENT INTERNAL PADDLE SET TO RESOLVE THE ISSUE. THIS WAS A MALFUNCTION OF THE INTERNAL PADDLE SET. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INTERNAL PADDLE SET FAILED TO DISCHARGE. THIS WAS DETECTED DURING A ROUTINE CHECK OF THE DEVICE; THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127326 INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS M4742A

    Patients

    Seq Age Sex Outcome Treatment
    1