BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL CE 0832

    MDR report key: 22091033 · Received May 27, 2025

    Report

    Report Number
    MW5170810
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    May 17, 2025
    Report Date
    May 20, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ZOLL DEFIBRILLATOR FAILED TO POWER ON, DESPITE WORKING PROPERLY A FEW HOURS EARLIER WHEN THE SAFETY CHECK WAS COMPLETED. A DIFFERENT ZOLL DEFIBRILLATOR WAS RETRIEVED FOR USE ON THE PATIENT. AFTER THE CODE, THE ERROR WAS RE-CREATED BY THE NURSING STAFF AND A RED "X" ON THE BATTERY LIGHT BEGAN FLASHING, SHOWING CHARGE STATUS OF >30% THEN 100% INTERMITTENTLY. A POWER FAILURE WAS ALSO RECREATED, AND THE UNIT WAS SENT TO BIOMED FOR EVALUATION. UPON BIOMED EVALUATION, VARIABLE FUNCTIONALITY WAS IDENTIFIED, EVEN AFTER REPLACING BATTERIES AS PREVIOUSLY DESCRIBED. THE UNIT WAS SENT TO THE MANUFACTURER FOR IDENTIFICATION AND REPAIR OF AN INTERNAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333030 ZOLL CE 0832 WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Life Threatening CALCIUM GLUCONATE.| DILAUDID| EPOGEN.| HUMALOG.| IODOSORB.| LOKELMA.| PROTONIX.| SENNA-DOCUSATE.| TYLENOL.| ZOFRAN.