BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1976454 · Received January 4, 2011

    Report

    Report Number
    3015876-2011-00009
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    June 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Removal / Correction Number
    3015876-12/21/10-004C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A RESULT OF OUR INVESTIGATION OF THE REPORTED ISSUE, A PRODUCT CORRECTION HAS BEEN IMPLEMENTED BY PHYSIO-CONTROL. THE PURPOSE OF THIS CORRECTION IS TO PROVIDE CUSTOMERS WHO OWN LIFEPAK 12 DEVICES AND LIFEPAK 12 AC (LINE POWER) ADAPTERS (ACPA) DISTRIBUTED PRIOR TO (B)(6) 2003 WITH A REFERENCE TO THE CURRENT DEVICE OPERATING INSTRUCTIONS (COPIED BELOW). THE NOTIFICATION LETTER WILL BRING ATTENTION TO THE OPERATING INSTRUCTIONS DESCRIPTION OF THE DEVICE BEHAVIOR ASSOCIATED TO THE TIMING OF DISCONNECTING THE LIFEPAK 12 FROM AC POWER AND TURNING THE DEVICE ON AND HOW TO RESPOND TO THE DEVICE BEHAVIOR WHEN IT OCCURS. "NOTE: THE SERVICE INDICATOR ON THE LIFEPAK 12 DEFIBRILLATOR/MONITOR MAY ILLUMINATE IF YOU TURN ON THE DEFIBRILLATOR/MONITOR AND DISCONNECT THE AC POWER ADAPTER FROM THE DEFIBRILLATOR/MONITOR OR POWER SOURCE AT THE SAME TIME. WAIT AT LEAST 2 SECONDS BETWEEN DISCONNECTING THE POWER ADAPTER AND TURNING ON THE DEFIBRILLATOR/MONITOR REGARDLESS OF THE ORDER OF THE AC ACTIONS. IF THE SERVICE INDICATOR COMES ON, CONTINUE TO USE THE DEFIBRILLATOR IF NEEDED. THE SERVICE CONDITION MAY BE CLEARED BY TURNING THE DEFIBRILLATOR OFF AND THEN BACK ON. IF THE SERVICE LED REMAINS LIT, REMOVE THE DEFIBRILLATOR FROM ACTIVE USE AND CONTACT YOUR SERVICE REPRESENTATIVE."

    Description of Event or Problem · 1

    PHYSIO-CONTROL HAS INVESTIGATED PRODUCT COMPLAINT REPORTS REGARDING DEVICE BEHAVIOR THAT COULD CAUSE A FAILURE OF THE DEVICE TO DISCHARGE WHEN INTENDED, IF THE DEVICE IS POWERED ON WITHIN 2 SECONDS AFTER REMOVING IT FROM AC POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA