BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2884185 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00944
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 25, 2012
    Report Date
    November 26, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE THERAPY CABLE ASSEMBLY WAS A BIT WORN AND REPLACED IT AS A PRECAUTION. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY CABLE ASSEMBLY AND OBSERVED IT TO BE FUNCTIONING NORMALLY. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE HAD FAILED TO SHOW THE PATIENT'S ECG RHYTHM THROUGH THE PADDLES LEAD. THE EMS AGENCY RESPONDED TO THE PATIENT HAVING A DRUG OVERDOSE. THE PATIENT WENT INTO CARDIAC ARREST DURING CARE AND A COUPLE TIMES DURING THE EVENT, THE CUSTOMER WAS UNABLE TO OBSERVE THE PATIENT'S ECG THROUGH PADDLES LEAD. THE CUSTOMER DID CONNECT THE PATIENT THROUGH THE LIMB LEAD ECG CABLE AND CONTINUED CARE. THE PATIENT RECEIVED FOUR (4) SHOCKS THROUGHOUT THE EVENT, BUT DID NOT SURVIVE. THE HEALTH CARE PROVIDER ON SCENE ADVISED THAT THE REPORTED FAILURE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR