BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR-D PADZ

    MDR report key: 21179947 · Received January 17, 2025

    Report

    Report Number
    1218058-2025-00003
    Event Type
    Death
    Date Received
    January 17, 2025
    Date of Event
    November 23, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    PMA / PMN Number
    P160015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS A UDI; SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CPR-D PADZ FROM THE EVENT WERE RETURNED TO ZOLL PAWTUCKET FOR EVALUATION. THE LEVEL OF ADHESION COULD NOT BE EVALUATED DUE TO THE CONDITION OF THE PADS. UPON VISUAL INSPECTION THERE WERE PORTIONS OF THE APEX AND STERNUM PAD THAT WERE COVERED WITH HAIR. THE IFU FOR THE CPR-D PADZ (AW R2001-96 REV L) CAUTIONS THE USER TO REMOVE EXCESSIVE CHEST HAIR. THE PADS WERE SCRAPPED AFTER TESTING. 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 DEFIBRILLATE A 75-YEAR-OLD MALE PATIENT, THE CPR-D PADZ WOULD NOT ADHERE TO THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145596 CPR-D PADZ ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0800-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death AED PLUS, SN (B)(6).