BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 11500038 · Received March 17, 2021

    Report

    Report Number
    0003015876-2021-00586
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 30, 2021
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, MODEL # OF THE INITIAL MEDWATCH REPORT INDICATES 3202488-021SECTION D4, MODEL # OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE 20E

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DETECT THE ELECTRODES THAT WERE CONNECTED TO THE DEVICE. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A THIRD-PARTY SERVICE AGENT EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION. AFTER PERFORMING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT DETECT THE ELECTRODES THAT WERE CONNECTED TO THE DEVICE. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE, IF NEEDED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400164 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 3202488-021

    Patients

    Seq Age Sex Outcome Treatment
    1