BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 9271384 · Received November 4, 2019

    Report

    Report Number
    9271384
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 30, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ZOLL ONE STEP CARDIOPULMONARY RESUSCITATION DEFIBRILLATOR ELECTRODE PACKAGING REQUIRES EXCESSIVE FORCE TO OPEN PACKAGING. TODAY, WHEN PHYSICIAN WAS OPENING A PACK, THE EXCESSIVE FORCE CASED SEPARATION OF THE CORD FROM THE ELECTRODE AND ANOTHER ELECTRODE HAD TO BE OBTAINED WHICH DELAYED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069836 ZOLL MEDICAL CORP AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION 8900-0024-01 3019B

    Patients

    Seq Age Sex Outcome Treatment
    1