BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 6973580 · Received October 24, 2017

    Report

    Report Number
    3015876-2017-01310
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 22, 2017
    Report Date
    November 27, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT (COMMON DEVICE NAME) INDICATES: DNA PROBE, TRICHOMONAS VAGINALIS / MJK. THE INITIAL MEDWATCH REPORT (COMMON DEVICE NAME) SHOULD INDICATE: DEFIBRILLATORS, AUTOMATIC, EXTERNAL / MKJ.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED A CLINICAL EVALUATION OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT. THIS DETERMINATION WAS DUE TO THE ECG SHOWING A PEA RHYTHM. ALSO, THE USER REPORTED ONLY HEARING "SHOCK ADVISED", DID NOT HEAR CHARGE TONE OR PROMPT TO PUSH THE SHOCK BUTTON. THIS MATCHES NO SHOCK ADVISED BEHAVIOR. IT IS LIKELY THAT THE USER DID NOT HEAR THE ENTIRE PROMPT. THIS MAY HAVE BEEN DUE TO ENVIRONMENTAL FACTORS. 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 EVALUATED THE CUSTOMER'S DEVICE AND OBSERVED THAT THE DEVICE HAD EXCESSIVE HOURS OF ON-TIME AND THE CHARGE-PAK WAS NOT MAINTAINED PROPERLY. THE CHARGE-PAK HAD EXPIRED IN 2014 AND THE DEVICE HAD BEEN USED FOR TWO DIFFERENT PATIENT EVENTS. ALSO, THE DEVICE DISPLAYED THE CHARGE-PAK BATTERY CHARGER INDICATOR HOWEVER, THE CUSTOMER DID NOT REPLACE THE CHARGE-PAK AT THAT TIME. THE OPERATING INSTRUCTIONS INDICATE THAT WHEN THE CHARGE-PAK BATTERY CHARGER INDICATOR IS PRESENT, THE CHARGE-PAK BATTERY CHARGER NEEDS TO BE REPLACED. PHYSIO-CONTROL RE-CHARGED THE BATTERIES AND INSTALLED A NEW CHARGE-PAK BATTERY CHARGER. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A TRAUMATIC CARDIAC ARREST, THE DEVICE PROMPTED "SHOCK ADVISED" HOWEVER THE DEVICE DID NOT CHARGE AND DID NOT GIVE A PROMPT TO PUSH THE SHOCK BUTTON. MEDICAL PERSONNEL WAITED APPROXIMATELY 10-15 SECONDS AND THEN REMOVED THE DEFIBRILLATION PADS AND DEVICE AND SWITCHED TO THEIR BACKUP DEVICE. THE BACKUP DEVICE DID NOT DISPLAY A SHOCKABLE RHYTHM AS THE PATIENT WAS IN A PULSELESS ELECTRICAL ACTIVITY (PEA) RHYTHM . THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750393 LIFEPAK CR(R) PLUS DEFIBRILLATOR DNA PROBE, TRICHOMONAS VAGINALIS MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR