BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 2914552 · Received January 14, 2013

    Report

    Report Number
    3015876-2013-00040
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THERE WAS AN IONIC CONTAMINATION ON FILTERS FL9, FL10 AND FL11 FROM THE ANALOG PCB ASSEMBLY. THE CONTAMINATION CAUSED LEAKAGE CURRENT THAT DEPLETED THE INTERNAL HLC BATTERIES AND THE CHARGE-PAK ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS PRESENT (CHARGE PAK, ATTENTION AND SERVICE WRENCH) ON THE DISPLAY AND THAT THE UNIT WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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
    21049 LIFEPAK CR® PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1