BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 20 DEFIBRILLATOR

    MDR report key: 8069005 · Received November 13, 2018

    Report

    Report Number
    MW5081195
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    August 31, 2018
    Report Date
    November 8, 2018
    Manufacturer
    PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LIFEPAK SCREEN STATED (INCORRECTLY) TO "CORRECT CABLE" WHEN CABLES WERE INSTALLED AND FUNCTIONING PROPERLY. ALSO, WHEN THE GRAY BUTTON WAS PUSHED TO OPEN THE DOOR THE LIFEPAK DID NOT CONVERT TO MANUAL MODE. CONTACT (B)(6) FOR ADD'L INFO. WE HAVE 36 LIFEPAK 20S AND 8 LIFEPAK 20ES WITH THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902541 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902542 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902543 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902544 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902545 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902546 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902547 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902548 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902549 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902550 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902551 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902601 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902602 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902603 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902604 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902605 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902606 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902607 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902608 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902609 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902610 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902611 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902612 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902613 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902614 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902615 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902616 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902617 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902618 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902619 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902620 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902621 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902622 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902623 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902624 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902625 LIFEPAK 20 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC / PHYSIO-CONTROL MANUFACTURING, INC.
    902626 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902627 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902628 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902629 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902630 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902631 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902632 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.
    902633 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL INC. / PHYSIO-CONTROL MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention