BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 2130202 · Received May 9, 2011

    Report

    Report Number
    3015876-2011-00371
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 15, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE OF THE MALFUNCTION TO BE AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL10, FROM THE ANALOG PCB ASSEMBLY DUE TO PROCESS RESIDUE ON THE BOARD SURFACE. THE EXCESSIVE CURRENT LEAKAGE DEPLETED THE INTERNAL HLC BATTERIES. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE CHARGE PAK AND ATTENTION ICONS. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND A MALFUNCTION THAT RAPIDLY DEPLETED THE INTERNAL HLC BATTERIES TO A CRITICAL LEVEL. THE DEVICE WAS NOT ABLE TO DELIVER DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    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 CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA