BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2508757 · Received March 26, 2012

    Report

    Report Number
    1218950-2012-01024
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Report Date
    February 28, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE SHOCK WAS NOT GETTING DELIVERED. THERE WAS NO REPORTED PT INVOLVEMENT. THE HOSPITAL BIOMED TECHNICIAN CONFIRMED THE PROBLEM WAS WITH THE EXTERNAL PADDLES. THE EXTERNAL PADDLES WERE REPLACED TO RESOLVE THE ISSUE. THE EXTERNAL PADDLES WERE NOT AVAILABLE FOR EVALUATION. WE WILL CONSIDER THIS A MALFUNCTION OF THE EXTERNAL PADDLES WHERE THE SHOCK WAS NOT DELIVERED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SHOCK WAS NOT GETTING DELIVERED. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS-DUP M4746A

    Patients

    Seq Age Sex Outcome Treatment
    1