BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 2053430 · Received March 17, 2011

    Report

    Report Number
    3015876-2011-00249
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 26, 2011
    Report Date
    September 10, 2018
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Removal / Correction Number
    3015876-02/08/2013-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THE CAUSE OF THE REPORTED FAILURE TO BE A FILTER, DESIGNATOR FL11 FROM THE ANALOG PCB ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT COMPLAINT REQUIRES A SUPPLEMENTAL MDR TO DOCUMENT THAT FIELD ACTION NUMBER 3015876-02/08/2013-001C IS RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SHOWING ITS CHARGE-PAK AND ATTENTION ICONS; HOWEVER, AFTER THE INITIAL DEVICE EVAL, IT WAS OBSERVED THAT THE DEVICE WOULD LOSE POWER AND POWER OFF ON ITS OWN. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Description of Event or Problem · 1

    SUPPLEMENTAL MDR IS REQUIRED TO DOCUMENT THAT FIELD ACTION NUMBER 3015876-02/08/2013-001C IS RELEVANT TO THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR® PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA