BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

    MDR report key: 11575276 · Received March 26, 2021

    Report

    Report Number
    1218058-2021-00036
    Event Type
    Death
    Date Received
    March 26, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946000189
    PMA / PMN Number
    K011541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOGRAPHS OF THE CUSTOMER'S REPORT WERE PROVIDED BY THE CUSTOMER AS PART OF THE INVESTIGATION. THE PHOTOGRAPHIC EVIDENCE SHOWED THAT THE ELECTRODE PADS WERE ASSEMBLED PROPERLY TO THE COATED SIDE OF THE STYRENE PLASTIC LINER. THIS DETERMINATION WAS MADE BY THE FOLDS AND MARKING AND THE LABELS ON THE STYRENE SHOWN IN THE PHOTOS. THE PHOTOS SUGGEST THAT AT SOME POINT, THE PADS WERE REMOVED FROM THE COATED SIDE AND WERE RE-APPLIED TO THE NON-COATED SIDE OF THE STYRENE LINER. THIS PREVENTED ANY FURTHER REMOVAL FROM THE STYRENE. A RETAINED SAMPLE EVALUATION OF LOT 1020 WAS PERFORMED. THE RETAINED SAMPLE WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORT. OUR INVESTIGATION FOR THE CUSTOMER'S REPORT WAS UNSUBSTANTIATED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6)-YEAR-OLD MALE PATIENT, 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 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
    472690 CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0800-01 1020 00847946000189

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death