BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 8148602 · Received December 10, 2018

    Report

    Report Number
    0003015876-2018-02089
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    October 18, 2018
    Report Date
    March 11, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    P160012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#, OF THE INITIAL MEDWATCH REPORT INDICATED: K033275 , PMA/510(K)#, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: P160012 NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT: CODE # 1476 - UNLABELED PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL ALSO OBSERVED THAT THE DEVICE WOULD NOT POWER ON WHEN PROMPTED. PHYSIO-CONTROL OBSERVED THAT THE DEVICE'S INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES HAD BECOME DEPLETED, WHICH CAUSED ALL THREE ICONS TO APPEAR ON THE DEVICE'S READINESS INDICATOR AND PREVENTED THE DEVICE FROM POWERING ON. DURING TESTING, PHYSIO RECHARGED THE INTERNAL HLC BATTERIES AND OBSERVED THAT THEY DISCHARGED AT A NORMAL RATE. AN INTERNAL INSPECTION WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHYSIO-CONTROL THAT WHILE PERFORMING THE INCOMING INSPECTION OF A DEVICE, IT WAS OBSERVED THAT IT HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON ITS READINESS DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTER PROVIDED PHYSIO-CONTROL WITH A PHOTOGRAPH OF THE DEVICE'S READINESS DISPLAY WHICH CONFIRMED THAT ALL THREE ICONS WERE PRESENT. A REPLACEMENT DEVICE WILL BE PROVIDED. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT WHILE PERFORMING THE INCOMING INSPECTION OF A DEVICE, IT WAS OBSERVED THAT IT HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON ITS READINESS DISPLAY. THE THREE ICONS BEING ILLUMINATED INDICATES THAT THE DEVICE MAY NOT BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988069 LIFEPAK CR(R) PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1