BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR)

    MDR report key: 13181579 · Received January 6, 2022

    Report

    Report Number
    1218058-2021-00152
    Event Type
    Death
    Date Received
    January 6, 2022
    Report Date
    December 16, 2021
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946023348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE ACTUAL ELECTRODES FROM THE EVENT WERE NOT AVAILABLE FOR EVALUATION. INSTEAD, ELECTRODES FROM RETAINED SAMPLES OF THE SAME LOT NUMBER 4919A WERE INVESTIGATED. EVALUATION OF THE ELECTRODES DID NOT REVEAL ANY IRREGULARITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS OBSERVED THE DATE OF THE EVENT, (B)(6) 2022, WAS BEYOND THE EXPIRATION DATE OF THE ELECTRODES (B)(6) 2022. PLEASE NOTE THAT THE STYRENE WE USE TO STORE THE ELECTRODES HAS A COATED AND NON-COATED SIDE. THE COATED SIDE ALLOWS THE RELEASE OF THE ELECTRODES, WHERE THE NON-COATED SIDE WILL NOT ALLOW THE RELEASE AND THEY WILL BE STUCK/VERY DIFFICULT TO REMOVE. THE ONE-STEP PEDIATRIC ELECTRODES UTILIZE A BOOK STYLE STYRENE TO ELIMINATE THE POSSIBILITY THAT THE ELECTRODE WILL BE APPLIED TO THE NON-COATED SIDE. THE FACT THAT ONE SIDE RELEASED SUGGESTS THE PADS WERE REMOVED AND REAPPLIED TO THE WRONG SIDE OF THE PACKAGING, BUT WE ARE UNABLE TO CONFIRM WITHOUT THE PHYSICAL ELECTRODES FOR INVESTIGATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) YEAR OLD PATIENT (GENDER UNKNOWN), THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING AND THEY WERE UNABLE TO ATTACH THEM TO THE PATIENT CAUSING A DELAY IN THERAPY. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794340 ONE STEP PEDIATRIC CPR ELECTRODE (1 PAIR) ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-000219-01 4919A 00847946023348

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Unknown Death