BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 15796793 · Received November 15, 2022

    Report

    Report Number
    15796793
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    November 1, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    R2018-33, 214234243- GEL ROLLED/DISPLACED ON BACK PAD. ONLY 2 ROUNDS OF COMPRESSIONS DONE. SENT BACK TO MFG. 2622B- ZOLL PADS WERE ATTACHED TO ZOLL DEFIB DEVICE AND WERE TESTED PER ROUTINE CHECK. PADS DID NOT FIRE AND FAILED TEST. ANOTHER SET OF PADS WAS ATTACHED TO THE DEVICE AND THIS TEST PASSED THE CHECK. WILL BE SENT BACK TO MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103486 ONESTEP COMPLETE, SINGLE, R SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ ZOLL MEDICAL CORPORATION 8900-0224-01 R2018-33

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown