BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 2872228 · Received December 13, 2012

    Report

    Report Number
    3015876-2012-00895
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 14, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. PHYSIO-CONTROL PERFORMED A CLINICAL EVALUATION ON THE REPORTED EVENT. THE CLINICAL EVALUATION DETERMINED THAT THE REPORTED FAILURE LIKELY DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT. THE HEALTHCARE PROVIDER ON SCENE INDICATED THAT THE DEVICE MALFUNCTION LIKELY DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A FAILURE OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U4 FROM THE DIGITAL PCB ASSEMBLY. IT WAS ALSO OBSERVED THAT THE ON/OFF BUTTON WAS PHYSICALLY DAMAGED, BUT THIS WAS NOT A CONTRIBUTING FACTOR IN THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT EVENT, FOLLOWING THE ARRIVAL OF THE CUSTOMER, THE DEVICE WAS CONNECTED TO THE PATIENT BUT WOULD NOT POWER ON. THE CUSTOMER APPLIED THEIR BACKUP AED WITHIN ONE (1) MINUTE OF THE INITIAL FAILURE AND THE DEVICE PROMPTED "NO SHOCK ADVISED." THE CUSTOMER CONTINUED WITH CPR AND THE DEVICE THEN PROMPTED THAT A SHOCK WAS ADVISED. THE BACKUP DEVICE DELIVERED TWO SUCCESSFUL DEFIBRILLATION SHOCKS. BY THE TIME THAT THE SECOND DEFIBRILLATION SHOCK WAS DELIVERED, THE LOCAL EMS DEPARTMENT CONTINUED CARE. THE PATIENT WAS PRONOUNCED DECEASED AT THE ARRIVAL TO THE HOSPITAL. THE CUSTOMER ADVISED THAT THEY BELIEVE THAT THE FAILURE OF THE INITIAL DEVICE TO POWER ON DID NOT HAVE ANY EFFECT ON THE OUTCOME OF THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR