BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2231052 · Received July 20, 2011

    Report

    Report Number
    1218950-2011-02060
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    June 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE L-SHAPED PLASTIC PIECE AROUND THE SHOCK BUTTONS IS LOOSE AND CAUSING THE BUTTONS TO BE MIS-ALIGNED. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER SCRAPPED THE PADDLES AND WERE NOT AVAILABLE FOR EVAL. THE CUSTOMER REPLACED THE PADDLES TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A PADDLES MALFUNCTION WHERE THE L-SHAPED PLASTIC PIECE AROUND THE SHOCK BUTTONS CAME LOOSE AND CAUSED THE SHOCK BUTTONS TO BE MIS-ALIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE L-SHAPED PLASTIC PIECE AROUND THE SHOCK BUTTONS IS LOOSE AND CAUSING THE BUTTONS TO BE MIS-ALIGNED. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PADDLES MKJ PHILIPS HEALTHCARE - ANDOVER M3542A

    Patients

    Seq Age Sex Outcome Treatment
    1