BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT PADZ, W/PRECONNECT, ADLT-12, MULTI-LANGUAGE

    MDR report key: 18335789 · Received December 15, 2023

    Report

    Report Number
    1218058-2023-00180
    Event Type
    Injury
    Date Received
    December 15, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. HOWEVER, THE PADS RETURNED WERE NOT APPLIED TO A PATIENT OR USED IN A CLINICAL EVENT. THE RETURNED PADS WERE DETERMINED TO HAVE STRONG ADHESION AND WERE ASSEMBLED ACCORDING TO SPECIFICATION. AN ECG SIGNAL WAS ACQUIRED USING THE RETURNED STAT PADZ AND ENERGY WAS DELIVERED SUCCESSFULLY. THE LOG WAS NOT AVAILABLE TO REVIEW FOR THE REPORTED EVENT DATE. THE STAT PADZ WERE SCRAPPED AFTER TESTING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D4 CATALOG # REMOVED. JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BUT NOT DOMESTICALLY DISTRIBUTED; IT IS ONLY DISTRIBUTED IN THE INTENDED GEOGRAPHY. THERE IS NO EXISTING UDI REGULATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, BURNS OF AN UNKNOWN DEGREE WERE FOUND ON THE PATIENT'S SKIN. PLEASE REFERENCE MEDWATCH REPORT 1220908-2023-00181 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052737 STAT PADZ, W/PRECONNECT, ADLT-12, MULTI-LANGUAGE ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-4003-49 3423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other