BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES ALS

    MDR report key: 4192466 · Received September 26, 2014

    Report

    Report Number
    4192466
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE DEFIBRILLATOR CHARGING LIGHT WAS NOT ON. THE UNIT WAS PLUGGED IN TO A GOOD OUTLET. THE POWER CORD EXTENSION WHERE IT PLUGS INTO THE DEFIBRILLATOR LOOKED LIKE IT WAS SEATED CORRECTLY, BUT WAS NOT. RESEATING THE EXTENSION POWER CORD PLUG INTO THE DEFIBRILLATOR RESTORED POWER TO THE UNIT. THE EXTENSION IS PROVIDED BY ZOLL TO ALLOW THE DEFIBRILLATOR TO BE DISCONNECTED AND MOVED EASILY WITHOUT TURNING THE DEFIBRILLATOR OVER. THE ISSUE IS THAT A POWER DISCONNECT AT THE EXTENSION AND DEFIBRILLATOR CONNECTOR INTERFACE IS CUMBERSOME TO CHECK AND INVOLVES LIFTING THE DEFIBRILLATOR.MANUFACTURER RESPONSE FOR DEFIBRILLATOR/MONITOR, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THIS ISSUE HAS NOT BEEN REPORTED TO US BY OTHER HOSPITALS. A ZOLL FSE I SPOKE WITH SAID HE INSTALLS A RETAINER BRACKET ON THE POWER CORD EXTENSION AT THE DEFIBRILLATOR POWER RECEPTACLE, BUT IT IS NOT SOMETHING THE COMPANY SAYS HE SHOULD DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600396 R SERIES ALS AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORP. R SERIES ALS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES