BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 7138556 · Received December 21, 2017

    Report

    Report Number
    3015876-2017-01646
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 21, 2017
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).     PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE CUSTOMER¿S DEVICE WAS ABLE TO PROPERLY RECOGNIZE A PATIENT CONNECTION AND CHARGE AND SHOCK APPROPRIATELY. THE DEFIBRILLATION ELECTRODES USED DURING THE EVENT WAS NOT EVALUATED BY PHYSIO AS THE CUSTOMER NO LONGER HAD THEM. THE CUSTOMER REPORTED THAT THE DEFIBRILLATION ELECTRODES HAD AN EXPIRATION DATE OF 4/17/2017, LOT CODE K032415-01. THE DEVICE SELF-TEST LOG DATA INDICATES THAT, ON (B)(6) 2017 AT 14:50:27, THE DATE OF THE EVENT, THE DEVICE WAS TURNED ON AND REMAINED ON FOR EXACTLY 5 MINUTES AND THEN SHUT OFF. THIS IS THE NORMAL BEHAVIOR WHEN THERE IS NO CONNECTION TO A PATIENT. THE ONLY PATIENT ECG RECORD IN DEVICE MEMORY WAS FROM MANUFACTURING TESTING ON (B)(6) 2012. DURING THE ELECTRONIC PERFORMANCE INSPECTION PROCEDURE (PIP) FOR THE DEVICE, THE CUSTOMER¿S DEVICE FAILED THE PIP TEST TWO OUT OF THREE TIMES FOR EXCESSIVE DEFIBRILLATOR CHARGE TIME, HOWEVER THIS WAS NOT RELATED TO THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER. BECAUSE OF THE PIP FAILURES, THE CUSTOMER WILL BE ADVISED TO REPLACE THEIR DEVICE. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED PATIENT EVENT AND ALSO CONCLUDED THAT THE DEVICE USAGE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT DETECT THE PATIENT THROUGH THE DEFIBRILLATION ELECTRODES DURING A PATIENT EVENT. THE DEVICE WOULD NOT ADVANCE PAST THE INITIAL VOICE PROMPTS TO CONNECT THE DEFIBRILLATION ELECTRODES TO THE PATIENT. THE CUSTOMER ADVISED THAT THE PATIENT DID HAVE SOME CHEST HAIR BUT IN THEIR OPINION IT WAS NOT EXCESSIVE AND NO SKIN PREPARATION WAS PERFORMED ON THE PATIENT BEFORE THE DEFIBRILLATION ELECTRODES WERE ATTACHED TO THE PATIENT. THE CUSTOMER PERFORMED CPR UNTIL THE POLICE ARRIVED ON THE SCENE AND USED THE POLICE OFFICER¿S AED. THE CUSTOMER BELIEVES THERE WAS APPROXIMATELY A 5 MINUTE DELAY IN PROVIDING THERAPY TO THE PATIENT. THE PARAMEDICS ARRIVED AFTER THE POLICE AND USED THEIR OWN DEVICE ON THE PATIENT. THE PATIENT WAS SHOCKED BY THE PARAMEDIC¿S DEVICE.   THE PATIENT A (B)(6) MALE, DID NOT SURVIVE. THE CUSTOMER, A HEALTH CARE PROFESSIONAL ADVISED THAT THEY BELIEVE THE DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME BECAUSE, UPON OUR ARRIVAL THE PATIENT WAS PULSELESS, UNRESPONSIVE, AND COLD AND SEEMED TO HAVE BEEN DOWN FOR QUITE SOME TIME. THE PATIENT WAS REPORTED TO HAVE LEFT WORK ON THE DAY OF THE EVENT AT APPROXIMATELY 12:45 PM AND WAS FOUND IN HIS CAR AT APPROXIMATELY 4:00 PM. THE SPECIFIC DOWNTIME IS UNKNOWN. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918246 LIFEPAK CR(R) PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC EXPRESS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR