BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL R DEFIBRILLATOR

    MDR report key: 21199985 · Received January 21, 2025

    Report

    Report Number
    MW5164982
    Event Type
    Injury
    Date Received
    January 21, 2025
    Report Date
    January 21, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUMMARY OF COMPLAINT: 3 OF THE MASIMO CORPORATION SP02 SENSORS ON THE ZOLL R SERIES DEFIBRILLATOR ARE NOT OPERATIONAL. WHEN CONDUCTING REGULAR MAINTENANCE, THE TECHNICIAN WAS UNABLE TO RECEIVE ANY READINGS. SWAPPED THE CONNECTOR PART WITH ANOTHER UNIT AND IT WORKED INDICATING THAT IT WAS THIS CABLE. THIS ISSUE OCCURRED TO THREE OTHER UNITS. THOSE UNITS WERE ECN: 119446 - SAME DAY SURGERY, ECN: 119474 - LABOR AND DELIVERY, ECN: 119452 - CATH LAB. REFERENCE REPORT #MW5164981, #MW5164983.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682195 ZOLL R DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown