BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 8588992 · Received May 7, 2019

    Report

    Report Number
    0003015876-2019-00799
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 18, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873871683
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE DOWNLOADED ELECTRONIC DATA FROM THE CUSTOMER'S DEVICE AND WAS ABLE TO VERIFY THE REPORTED ISSUE. WHILE LOOSE KEP NUTS WERE OBSERVED DURING THE DEVICE EVALUATION, WHICH COULD CAUSE THE DEVICE TO UNEXPECTEDLY LOSE POWER WHILE CHARGING, THE CAUSE OF THE REPORTED ISSUE COULD STILL NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND ON BY ITSELF SEVERAL TIMES DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THEIR DEVICE SHOCKED THE PATIENT SIX TIMES SUCCESSFULLY. ON THE SEVENTH THROUGH NINTH ATTEMPT TO SHOCK THE PATIENT, THE DEVICE WOULD REACH 200J AND THEN POWERED ITSELF OFF AND BACK ON AGAIN. ONE BATTERY INSTALLED IN THE DEVICE AT THE TIME OF THE EVENT WAS AT FULL CAPACITY AND THE OTHER INSTALLED BATTERY HAD PARTIAL CHARGE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED POWER ISSUE. PHYSIO DID OBSERVE THAT THE KEP NUTS FOR BATTERY PINS IN THE CUSTOMER¿S DEVICE WERE LOOSE. THE KEP NUTS WERE TIGHTENED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. LOOSE BATTERY PINS CAN CAUSE THE DEVICE TO INAPPROPRIATELY LOSE POWER; HOWEVER THE CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND ON BY ITSELF SEVERAL TIMES DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THEIR DEVICE SHOCKED THE PATIENT SIX TIMES SUCCESSFULLY. ON THE SEVENTH THROUGH NINTH ATTEMPT TO SHOCK THE PATIENT, THE DEVICE WOULD REACH 200J AND THEN POWERED ITSELF OFF AND BACK ON AGAIN. ONE BATTERY INSTALLED IN THE DEVICE AT THE TIME OF THE EVENT WAS AT FULL CAPACITY AND THE OTHER INSTALLED BATTERY HAD PARTIAL CHARGE. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE PATIENT OUTCOME REPORTED. NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. PHYSIO-CONTROL HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION ON THE EVENT AND PATIENT, BUT HAS BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381101 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873871683

    Patients

    Seq Age Sex Outcome Treatment
    1