BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT PADZ HVP MULTI FUNCTION ELECTRODES

    MDR report key: 7228292 · Received January 30, 2018

    Report

    Report Number
    1218058-2018-00008
    Event Type
    Death
    Date Received
    January 30, 2018
    Date of Event
    January 23, 2018
    Report Date
    January 23, 2018
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODE PACKAGING WAS RECEIVED AT ZOLL MEDICAL CORPORATION FOR EVALUATION. VISUAL INSPECTION OF THE ELECTRODE PACKAGING PROVIDES EVIDENCE THAT THE ELECTRODES WERE IN THE PACKAGING DURING THE TIME OF MANUFACTURE. THE ELECTRODE PACKAGING SHOWS A VOID IN THE ADHESIVE HEAT SEAL LINE WHERE THE GROMMET IS SECURED AROUND THE CABLE AT THE PROPER LOCATION. THE GROMMET IS ATTACHED AS PART CABLE ASSEMBLY AND CANNOT BE SEALED WITHIN THE PACKAGING WITHOUT BEING INSTALLED ONTO THE CABLE BASED ON THE FIXTURE USED TO AID IN THE SEALING PROCESS. OUR EVALUATION HAS CONCLUDED THAT THE ELECTRODES WERE INSIDE OF THE PACKAGING PRIOR TO DISTRIBUTION OF THE PRODUCT. THEREFORE THIS CLAIM IS BEING CLOSED AS EVIDENCE SUPPORTS REPORT WAS UNSUBSTANTIATED. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PATIENT (AGE UNKNOWN) THE ELECTRODE PACKAGING WAS OPENED AND IT WAS DISCOVERED THAT THERE WERE NO ELECTRODES INSIDE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODES TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT DUE TO THE DELAY IN THERAPY, THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71754 STAT PADZ HVP MULTI FUNCTION ELECTRODES DEFIB/PACING ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4004 4417D 00847946016456

    Patients

    Seq Age Sex Outcome Treatment
    1 Death