BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3213517 · Received July 9, 2013

    Report

    Report Number
    3015876-2013-00593
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 11, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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 OBSERVED THAT THE DIGITAL PCB ASSEMBLY CAUSED THE DEVICE NOT TO POWER ON. PHYSIO-CONTROL THEN FURTHER EVALUATED THE DIGITAL PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A CRYSTAL, DESIGNATOR Y1 ON THE DIGITAL PCB ASSEMBLY, THAT DID NOT OSCILLATE. THIS CRYSTAL NOT OSCILLATING CAUSED THAT THE REAL-TIME CLOCK COULD NOT FUNCTION TO BOOT THE CIRCUITRY. THE DEVICE WAS NO LONGER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SALES REPRESENTATIVE THAT THE CUSTOMER¿S DEVICE DID NOT BOOT UP AFTER THE LID OF THE DEVICE WAS OPENED. THE DEVICE'S READINESS DISPLAY SHOWED "OK". WHEN CLOSING THE LID, THE "OK" ICON DISAPPEARED FROM THE DISPLAY. UPON EVALUATION BY PHYSIO-CONTROL, THE DEVICE DISPLAYED THREE ICONS (ATTENTION, CHARGE-PAK AND SERVICE INDICATOR) IN THE READINESS DISPLAY. THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED; HOWEVER, THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. A BACK-UP DEVICE WAS USED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314257 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR