BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3964871 · Received July 29, 2014

    Report

    Report Number
    3015876-2014-00864
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    December 28, 2018
    Report Date
    January 18, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Removal / Correction Number
    3015876-12/28/2018-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER EXTENSIVE TESTING OF THE CUSTOMER'S DEVICE, PHYSIO-CONTROL WAS STILL UNABLE TO DUPLICATE THE REPORTED ISSUE. AS A PRECAUTION, PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND THE DEVICE'S BATTERY PINS. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED ISSUE. 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 HAS DETERMINED THAT THE LIKELY CAUSE OF THE REPORTED ISSUE WAS DUE TO A FIELD PROGRAMMABLE GATE ARRAY COMPONENT (¿FPGA¿) ON THE SYSTEM PCB ASSEMBLY. TIMING ISSUES IN THE FPGA FIRMWARE MAY INTERMITTENTLY PREVENT A REQUIRED SYSTEM REBOOT FOLLOWING A DEFIBRILLATOR SHOCK WHICH RESULTS IN THE LOCKUP ISSUE. DURING THE EVALUATION, THE DEVICE LOCKUP CONDITION OCCURRED ONCE IN EVERY 800 TO 1200 DEFIBRILLATOR DISCHARGE CYCLES. NEW FPGA FIRMWARE HAS BEEN CREATED TO RESOLVE THE TIMING ISSUES THAT WERE IDENTIFIED. VALIDATION TESTING OF THE NEW FPGA FIRMWARE HAS CONFIRMED THAT THE UPDATED FIRMWARE IS EFFECTIVE IN CORRECTING INTERMITTENT DEVICE LOCKUP ISSUE FOLLOWING A DEFIBRILLATOR SHOCK HAS BEEN CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THEIR DEVICE FROZE SHORTLY AFTER PROVIDING A DEFIBRILLATION SHOCK. THE PATIENT, A (B)(6) FEMALE, HAD RECENTLY BEEN DISCHARGED FROM THE HOSPITAL WHEN THE EVENT OCCURRED. BYSTANDER CPR WAS PERFORMED ON THE PATIENT UNTIL THE EMS TEAM ARRIVED AND TOOK OVER CARE APPROXIMATELY 7-10 MINUTES AFTER THE EMERGENCY CALL WAS RECEIVED. THE EMS TEAM PROVIDED THE PATIENT WITH THREE (3) DEFIBRILLATION SHOCKS AND IT WAS AFTER THE 3RD SHOCK THAT THE DEVICE BECAME FROZEN. A PARAMEDIC REMOVED THE BATTERIES, WHICH CYCLED THE POWER, AND THE UNIT POWERED BACK ON WITH NO FURTHER ISSUES. THE PARAMEDIC ESTIMATED THAT THE DELAY IN CARE WAS LESS THAN 30 SECONDS. THE PATIENT DID NOT SURVIVE THE EVENT; HOWEVER, THE PARAMEDIC WHO WAS ON SCENE ADVISED THAT THE DELAY IN CARE DUE TO THE REPORTED ISSUE WAS MINIMAL AND IT WAS HIS OPINION THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THEIR DEVICE FROZE SHORTLY AFTER PROVIDING A DEFIBRILLATION SHOCK. THE PATIENT, A (B)(6) YEAR-OLD FEMALE, HAD RECENTLY BEEN DISCHARGED FROM THE HOSPITAL WHEN THE EVENT OCCURRED. BYSTANDER CPR WAS PERFORMED ON THE PATIENT UNTIL THE EMS TEAM ARRIVED AND TOOK OVER CARE APPROXIMATELY 7-10 MINUTES AFTER THE EMERGENCY CALL WAS RECEIVED. THE EMS TEAM PROVIDED THE PATIENT WITH THREE (3) DEFIBRILLATION SHOCKS AND IT WAS AFTER THE 3RD SHOCK THAT THE DEVICE BECAME FROZEN. A PARAMEDIC REMOVED THE BATTERIES, WHICH CYCLED THE POWER, AND THE UNIT POWERED BACK ON WITH NO FURTHER ISSUES. THE PARAMEDIC ESTIMATED THAT THE DELAY IN CARE WAS LESS THAN 30 SECONDS. THE PATIENT DID NOT SURVIVE THE EVENT; HOWEVER, THE PARAMEDIC WHO WAS ON SCENE ADVISED THAT THE DELAY IN CARE DUE TO THE REPORTED ISSUE WAS MINIMAL AND IT WAS HIS OPINION THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442411 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR