BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 2802104 · Received October 23, 2012

    Report

    Report Number
    3015876-2012-00791
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 10, 2018
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Removal / Correction Number
    3015876-02/08/2013-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE EXCESSIVE OFF CURRENT LEAKAGE FROM THE ANALOG PCB ASSEMBLY DUE TO PROCESS RESIDUE UNDER THE FL9 FILTER. THE CURRENT LEAKAGE DEPLETED THE INTERNAL HLC BATTERIES.A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN FOR EVALUATION AND CONTINUES TO INVESTIGATE THE REPORTED ISSUE. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    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 DISPLAYED THE CHARGE PAK, ATTENTION, AND WRENCH INDICATORS, AND FAILED TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    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 CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1