BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 8067242 · Received November 13, 2018

    Report

    Report Number
    0003015876-2018-01893
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 24, 2018
    Report Date
    February 10, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 MODEL # OF THE INITIAL MEDWATCH REPORT INDICATES: MKJ. SECTION D4 MODEL #OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: CRPLUS.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE 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). PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THEIR DEVICE IS NOT FIELD SERVICEABLE AND NO LONGER UNDER WARRANTY. PHYSIO-CONTROL RECOMMENDED THAT THE DEVICE BE PERMANENTLY REMOVED FROM SERVICE AND THAT A REPLACEMENT UNIT BE OBTAINED. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. DEVICE NOT EVALUATED BY MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE 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
    906619 LIFEPAK CR(R) PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1