BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 2864283 · Received December 10, 2012

    Report

    Report Number
    3015876-2012-00882
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    August 16, 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
    SZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN ELECTRONICALLY LEAKY FILTER, DESIGNATOR FL9, FROM THE ANALOG PCB ASSEMBLY WHICH CAUSED THE INTERNAL HLC BATTERY TO DEPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND 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 TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE DID NOT POWER ON AND THAT THE CHARGE-PAK, ATTENTION AND SERVICE SYMBOLS WERE LIT. 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