BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4192974 · Received October 22, 2014

    Report

    Report Number
    3015876-2014-01254
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL OFFERED TO PROVIDE TECHNICAL ASSISTANCE TO THE CUSTOMER, INCLUDING AN OFFER TO ASSIST WITH DOWNLOADING THE ELECTRONIC PATIENT RECORD(S) FROM THE EVENT; HOWEVER, THE CUSTOMER HAS DECLINED ALL OFFERS OF ASSISTANCE AT THIS TIME. THE CUSTOMER ADVISED THAT THEY STILL HAVE THE DEVICE IN THEIR POSSESSION, BUT WILL NOT RELEASE IT FOR EVALUATION. A PHYSIO-CONTROL CLINICAL SPECIALIST EVALUATED THE FACTS FROM THE EVENT AND CONCLUDED THAT THE DEVICE USE DID NOT LIKELY CONTRIBUTE TO THE PATIENT'S OUTCOME. THE CLINICAL SPECIALIST CAME TO THIS CONCLUSION BASED ON THE PATIENT'S UNKNOWN DOWNTIME AND THAT IT WAS AN UNWITNESSED EVENT. ADDITIONALLY, THE FIRST RESPONDERS REPORTED THAT THE PATIENT WAS COLD TO THE TOUCH.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT, THEIR AED (DEVICE) WOULD NOT DETECT THAT THE PATIENT WAS ATTACHED. THE DEVICE CONTINUED TO PROMPT THE DEVICE USER TO REMOVE THE PATIENT'S CLOTHING AND TO CONNECT THE ELECTRODES TO THE PATIENT, EVEN THOUGH THE PATIENT'S CLOTHING HAD BEEN REMOVED AND THE ELECTRODES PLACED ONTO THE PATIENT'S CHEST. THE PATIENT, (B)(6) YEAR-OLD MALE, HAD BEEN FOUND UNCONSCIOUS AND UNRESPONSIVE. FIRST RESPONDERS ALSO NOTED THAT THE PATIENT WAS COLD TO THE TOUCH, BUT THAT RIGOR MORTIS HAD NOT YET SET IN. THE FIRST RESPONDERS IMMEDIATELY STARTED CPR ON THE PATIENT AND THE DEVICE WAS ATTACHED TO THE PATIENT. THE DEVICE THEN CONTINUED TO INSTRUCT THE DEVICE USER TO REMOVE THE PATIENT'S CLOTHING AND TO CONNECT THE ELECTRODES TO THE PATIENT. THE DEVICE USER THEN MOVED THE DEFIBRILLATION ELECTRODES CABLES AROUND AND THEN THE PATIENT WAS DETECTED BY THE DEVICE. THE DEVICE THEN PROVIDED A "SHOCK ADVISED" DECISION AND ONE DEFIBRILLATION SHOCK WAS PROVIDED TO THE PATIENT. THE DEVICE THEN PERFORMED ADDITIONAL ANALYSES BUT CAME BACK WITH "NO SHOCK ADVISED" DECISIONS EACH TIME. A NURSE, WHO WAS PART OF THE TEAM OF FIRST RESPONDERS, THEN POWERED THE DEVICE OFF AND REPLACED THE DEFIBRILLATION ELECTRODES. THE PATIENT DID NOT SURVIVE THE EVENT; HOWEVER, THE FIRST RESPONDERS WHO EVALUATED AND TREATED THE PATIENT BELIEVE THAT HE WAS LIKELY ALREADY DECEASED WHEN THEY ARRIVED AND BEGAN TREATMENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672351 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR