BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2

    MDR report key: 3874926 · Received June 16, 2014

    Report

    Report Number
    3015876-2014-00656
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    December 28, 2018
    Report Date
    January 22, 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
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS PERFORMED AN INITIAL EVALUATION OF THE DEVICE.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

    (B)(4). 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

    AFTER ADDITIONAL EVALUATION OF THE DEVICE, PHYSIO-CONTROL HAS BEEN ABLE TO VERIFY THE REPORTED FAILURE BUT HAS BEEN UNSUCCESSFUL IN DETERMINING THE CAUSE OF THE REPORTED FAILURE. THE CUSTOMER HAS RECEIVED A REPLACEMENT DEVICE.

    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.

    Additional Manufacturer Narrative · 1

    AFTER ADDITIONAL INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE THE CODING IN THE CONTINUOUS WAVEFORM MANAGEMENT SOFTWARE THAT DOES NOT CORRECTLY ACCOUNT FOR A SPECIFIC CORNER CONDITION, WHEN THE DEVICE REMAINS ON FOR GREATER THAN 72 HOURS. SPECIFICALLY, THE SPO2 WAVEFORM BUFFERING LOGIC FAILS TO ACCOUNT FOR A CONDITION WHEN PATIENT DATA RECORDING IS TERMINATED DUE TO SPACE CONSIDERATIONS WHILE THE WAVEFORM DISPLAY CONTINUES. A CORRECTION TO THE DESIGN OF THE DEVICE SOFTWARE WILL BE MADE TO ELIMINATE THE CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A DEVICE TESTING SESSION, THE DEVICE CHARGED AND DELIVERED DEFIBRILLATION ENERGY SUCCESSFULLY. AFTER THE DELIVERY OF ENERGY, THE SCREEN STAYED BLACKED OUT AND THE DEVICE WAS NOT RESPONSIVE TO ANY BUTTON SELECTIONS AND APPEARED LOCKED UP. THE DEVICE USER POWER CYCLED THE DEVICE AND ONCE IT POWERED BACK ON, NORMAL FUNCTIONALITY WAS OBSERVED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A DEVICE TESTING SESSION, THE DEVICE CHARGED AND DELIVERED DEFIBRILLATION ENERGY SUCCESSFULLY. AFTER THE DELIVERY OF ENERGY, THE SCREEN STAYED BLACKED OUT AND THE DEVICE WAS NOT RESPONSIVE TO ANY BUTTON SELECTIONS AND APPEARED LOCKED UP. THE DEVICE USER POWER CYCLED THE DEVICE AND ONCE IT POWERED BACK ON, NORMAL FUNCTIONALITY WAS OBSERVED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352188 LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15

    Patients

    Seq Age Sex Outcome Treatment
    1