BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3801596 · Received May 9, 2014

    Report

    Report Number
    3015876-2014-00518
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Removal / Correction Number
    3015876-01/04/2017-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND VERIFIED FROM THE DOWNLOADED ELECTRONIC PATIENT RECORD THAT UNEXPECTED DEVICE POWER OFF'S HAD OCCURRED. THE DEVICE WAS TESTED WITH THE RETURNED BATTERY. IT WAS OBSERVED THAT THE DEVICE'S READINESS DISPLAY SHOWED OK AND THAT THE BATTERY'S CHARGE LEVEL WAS 75%. THE DEVICE COULD CHARGE AND SHOCK DEFIBRILLATION ENERGY. THE DEVICE, WITH THE BATTERY INSERTED, WAS POWERED ON AND SET ONTO A VIBRATION TABLE TO SHAKE THE DEVICE REPEATEDLY. THE DEVICE WAS THEN RANDOMLY POWERED ON TO MONITOR A TEST PATIENT FOR 6 DAYS. NO DISCREPANCIES WERE OBSERVED. A CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PERFORMED AN INITIAL CLINICAL REVIEW ON 04/18/14 OF ELECTRONIC PATIENT RECORDS THAT INCLUDED TWO DEVICE POWER-ON EVENTS; IT WAS DETERMINED THAT DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S OUTCOME. SERVICE INFORMATION WAS LATER RECEIVED INDICATING THERE WERE TWO PRIOR DEVICE POWER-ON EVENTS (A TOTAL OF FOUR) FOR WHICH THERE ARE NO ELECTRONIC PATIENT RECORDS. WITHOUT THE RECORDS FROM THE FIRST TWO DEVICE POWER-ON EVENTS, IT CANNOT BE DETERMINED IF THE PATIENT¿S ECG RHYTHM WAS SHOCKABLE. THEREFORE, IT CANNOT BE DETERMINED WHETHER DEVICE USE CONTRIBUTED TO THE PATIENT¿S OUTCOME.

    Additional Manufacturer Narrative · 1

    THE SECOND SUPPLEMENTAL MEDWATCH REPORT INDICATES: PHYSIO-CONTROL PERFORMED AN INITIAL CLINICAL REVIEW ON 04/18/2014 OF ELECTRONIC PATIENT RECORDS THAT INCLUDED TWO DEVICE POWER-ON EVENTS; IT WAS DETERMINED THAT DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S OUTCOME. SERVICE INFORMATION WAS LATER RECEIVED INDICATING THERE WERE TWO PRIOR DEVICE POWER-ON EVENTS (A TOTAL OF FOUR) FOR WHICH THERE ARE NO ELECTRONIC PATIENT RECORDS. WITHOUT THE RECORDS FROM THE FIRST TWO DEVICE POWER-ON EVENTS, IT CANNOT BE DETERMINED IF THE PATIENT¿S ECG RHYTHM WAS SHOCKABLE. THEREFORE, IT CANNOT BE DETERMINED WHETHER DEVICE USE CONTRIBUTED TO THE PATIENT¿S OUTCOME. THE SECOND SUPPLEMENTAL MEDWATCH REPORT SHOULD INDICATE: PHYSIO-CONTROL PERFORMED AN INITIAL CLINICAL REVIEW ON 04/18/2014 OF ELECTRONIC PATIENT RECORDS THAT INCLUDED TWO DEVICE POWER-ON EVENTS; IT WAS DETERMINED THAT DEVICE USE DID NOT CONTRIBUTE TO THE PATIENT'S OUTCOME. SERVICE INFORMATION WAS LATER RECEIVED INDICATING THERE WERE TWO PRIOR DEVICE POWER-ON EVENTS (A TOTAL OF FOUR) FOR WHICH THERE ARE NO ELECTRONIC PATIENT RECORDS. WITHOUT THE RECORDS FROM THE FIRST TWO DEVICE POWER-ON EVENTS, IT CANNOT BE DETERMINED IF THE PATIENT¿S ECG RHYTHM WAS SHOCKABLE. THEREFORE, IT CANNOT BE DETERMINED WHETHER DEVICE USE CONTRIBUTED TO THE PATIENT¿S OUTCOME. AFTER ADDITIONAL INVESTIGATION IT HAS BEEN CONCLUDED THAT THE LIKELY CAUSE OF THE REPORTED ISSUE WAS DUE TO INCREASED ELECTRICAL CONTACT RESISTANCE OF THE BATTERY CONNECTOR CONTACTS. THE INCREASED ELECTRICAL CONTACT RESISTANCE HAS BEEN ATTRIBUTED TO MOVEMENT OF THE MATING CONTACTS CAUSED BY DEVICE STORAGE IN A HIGH VIBRATION ENVIRONMENT, SUCH AS A FIRE TRUCK OR EMERGENCY VEHICLE, WHICH CAN CAUSE THE GOLD PLATING ON THE CONTACT SURFACES TO WEAR THROUGH AND EXPOSE THE BASE NICKEL AND COPPER LAYERS. CORROSION OR OXIDATION BUILD UP ON THE EXPOSED BASE NICKEL AND COPPER LAYERS COULD THEN CAUSE INCREASED CONTACT RESISTANCE AND MAY LEAD TO INTERMITTENT ELECTRICAL CONNECTION TO ONE OR MORE OF THE BATTERY CONTACTS WHICH COULD CAUSE THE DEVICE TO INTERMITTENTLY LOSE POWER.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PERFORMED AN ADDITIONAL CLINICAL ANALYSIS ON THE REPORTED EVENT. PHYSIO CONCLUDED THAT THERE IS NO INFORMATION TO REASONABLY CONCLUDE THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S OUTCOME; THEREFORE, "TYPE OF REPORTABLE EVENT", HAS BEEN CHANGED FROM "MALFUNCTION" TO "DEATH".

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE, BUT COULD NOT VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY. PHYSIO-CONTROL ALSO PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT. IT WAS OBSERVED THAT DEFIBRILLATION WAS NOT INDICATED BASED ON THE PATIENT'S ECG. ON THE FIFTH ANALYSIS THAT WAS DONE, A SHOCKABLE RHYTHM WAS DETECTED, AND A DEFIBRILLATION SHOCK WAS DELIVERED ACCORDINGLY. PHYSIO-CONTROL DETERMINED THAT THE REPORTED DEVICE FAILURE DID NOT CONTRIBUTE TO THE PATIENT'S OUTCOME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT THEIR DEVICE SHUT ITSELF OFF THREE TIMES WHEN THEY USED IT ON A PATIENT. THE DEVICE WAS POWERED BACK ON EACH TIME. AFTER IT WAS POWERED ON FOR THE FOURTH TIME, IT WORKED PROPERLY. ONE SHOCK WAS DELIVERED WITH THE DEVICE. THEN THE EMS ARRIVED ON SCENE. THE DEVICE WAS POWERED OFF MANUALLY, AND THE DEFIBRILLATOR FROM THE EMS WAS THEN USED TO CONTINUE THE INTERVENTION. THREE ADDITIONAL DEFIBRILLATION SHOCKS WERE DELIVERED, BUT WITHOUT SUCCESS. THE PATIENT WAS DECLARED DEAD BY THE EMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280375 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death