BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2983291 · Received February 28, 2013

    Report

    Report Number
    3015876-2013-00165
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    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

    PHYSIO-CONTROL'S FURTHER EVALUATION OF THE DEVICE AT THE FAILURE ANALYSIS CENTER VERIFIED THE DEVICE FAILURE TO POWER ON. THE CAUSE FOR THE MALFUNCTION WAS A DISLODGED LID AND POWER LATCH FROM THE MOUNTING SHAFT. THE LATCH ASSEMBLY CONNECTS TO THE ON/OFF BUTTON SWITCH FLEX ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE SALES REPRESENTATIVE.

    Description of Event or Problem · 1

    A PHYSIO-CONTROL SALES REPRESENTATIVE REPORTED THAT ONE OF THEIR FULLY FUNCTIONAL DEMO DEVICES WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88377 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1