BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT-PADZ II

    MDR report key: 20858043 · Received December 5, 2024

    Report

    Report Number
    1218058-2024-00113
    Event Type
    Death
    Date Received
    December 5, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016326
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 STAT-PADZ II WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER PROVIDED PHOTOS SHOWING THE ELECTRODES AND THE POUCH, BUT WITH NO STYRENE BOOKLET. THE PADS APPEARED TO BE ADHERED TO THE CARDBOARD INSERTS, COVERING THE GEL AND SURROUNDING THE FOAM, WHICH APPEARS TO BE DAMAGED/TORN. THE CARDBOARD INSERTS ARE PLACED ON THE NON-RELEASE SIDE OF THE STYRENE, OPPOSITE TO THE PADS. IF THE PADS WERE APPLIED TO THE NON-RELEASE SIDE OF THE STYRENE, THEY WOULD ADHERE TO CARDBOARD AND THE EDGES OF THE STYRENE, DAMAGING THE SURROUNDING FOAM UPON REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 1023 OF THE STAT-PADZ II ELECTRODES SHOWED NO ANOMALIES WITH THE ASSEMBLY AND THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NO SIMILAR EVENTS REPORTED. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE PADS WERE MISSING THE FILMS BETWEEN THE CARDBOARD AND THE GEL AFTER OPENING/REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296646 STAT-PADZ II DEFIB/PACING ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-0801-01 1023 00847946016326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death ZOLL DEFIBRILLATION ELECTRODES 8900-0802-02