BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 7110940 · Received December 12, 2017

    Report

    Report Number
    3015876-2017-01566
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 8, 2017
    Report Date
    March 28, 2018
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND DOWNLOADED THE DEVICE'S ELECTRONIC RECORDS. PHYSIO REVIEWED ALL OF THE RECORDS AND CONCLUDED THAT THE USER DID NOT TURN ON THE SYNC FUNCTION DURING THE REPORTED EVENT. FOLLOWING A 100 JOULE ASYNCHRONOUS DEFIBRILLATOR SHOCK, THE PATIENT'S ECG RHYTHM CONVERTED TO VENTRICULAR FIBRILLATION. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CLINICAL REVIEW OF THE REPORTED EVENT WAS ALSO PERFORMED BY PHYSIO-CONTROL AND DETERMINED THAT THE DEVICE USE CONTRIBUTED TO THE REPORTED ISSUE DUE TO USE ERROR. THERE WAS NO FAILURE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE A PATIENT WAS IN THE VENTRICULAR TACHYCARDIA RHYTHM, MEDICAL PERSONNEL HAD CHARGED THEIR DEVICE, IN ORDER TO PROVIDE A SYNCHRONIZED CARDIOVERSION SHOCK TO THE PATIENT; HOWEVER WHEN THE SHOCK BUTTON WAS PRESSED THE DEVICE DELIVERED A 100 JOULES SHOCK TO THE PATIENT. THE PATIENT'S RHYTHM CONVERTED TO VENTRICULAR FIBRILLATION FOLLOWING THE 100 JOULES ASYNCHRONOUS SHOCK. THREE ADDITIONAL ASYNCHRONOUS DEFIBRILLATOR SHOCKS (200 JOULES, 300 JOULES, 360 JOULES) WERE ADMINISTERED TO THE PATIENT. THE PATIENT, A 65 YEAR OLD MALE, SURVIVED THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887132 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening