BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER RESISTANT EXTERNAL PADDLES

    MDR report key: 2170851 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01764
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A PADDLE SET FAILURE [SHOCK PEDAL]. THERE WAS NO REPORTED PT INVOLVEMENT. THE FAILED 5 YEAR OLD PADDLE SET WAS SCRAPPED AND THE CUSTOMER ORDERED A REPLACEMENT. BASED ON THE CUSTOMERS REPORT WE WILL CONSIDER THIS A PADDLE SET FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PADDLE SET FAILURE [SHOCK PEDAL]. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATER RESISTANT EXTERNAL PADDLES MKJ PHILIPS HEALTHCARE - ANDOVER M3543A

    Patients

    Seq Age Sex Outcome Treatment
    1