BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 6065218 · Received October 28, 2016

    Report

    Report Number
    3015876-2016-01288
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 28, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Removal / Correction Number
    3015876-02/08/2013-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. 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

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND VERIFIED THE OBSERVED ISSUE.  PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL9 FROM THE ANALOG PCB ASSEMBLY.  THE ELECTRICALLY LEAKY FILTER CAUSED THE INTERNAL HLC BATTERIES TO BECOME DEPLETED.

    Description of Event or Problem · 1

    A DISTRIBUTOR RETURNED THE CUSTOMER'S DEVICE TO PHYSIO-CONTROL FOR EVALUATION. THE DISTRIBUTOR DID NOT PROVIDE A REASON FOR THE RETURN OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE CUSTOMER'S DEVICE, PHYSIO OBSERVED THAT A LOW-BATTERY INDICATOR WAS PRESENT ON THE READINESS DISPLAY. PHYSIO ALSO OBSERVED DIFFICULTY WITH POWERING THE DEVICE ON DUE TO THE ON/OFF BUTTON STICKING. FURTHERMORE, PHYSIO OBSERVED THAT THE DEVICE WOULD POWER OFF BY ITSELF WHEN ATTEMPTING TO CHARGE AND SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716044 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1