BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3110029 · Received May 13, 2013

    Report

    Report Number
    3015876-2013-00388
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE ATTEMPTS TO RECEIVE THE DEVICE FROM THE CUSTOMER FOR EVALUATION, PHYSIO-CONTROL HAS BEEN UNSUCCESSFUL IN OBTAINING THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN FOR EVALUATION AND CONTINUES TO INVESTIGATE THE REPORTED PROBLEM. PHYSIO 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 THAT THE DEVICE INTERNAL HLC BATTERY HAD PROBLEM EVEN WHEN RECHARGED. THIS WAS REPORTED TO BE AN OUT OF BOX FAILURE AND THERE WERE NO FURTHER DETAILS REGARDING THE PROBLEM. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211527 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1