BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

    MDR report key: 14465361 · Received May 21, 2022

    Report

    Report Number
    1218058-2022-00047
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 29, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE ELECTRODE PADS WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. TESTING CONFIRMED THE ELECTRODE PADS WERE ASSEMBLED CORRECTLY AND THE APEX PAD WAS REAPPLIED TO THE WRONG SIDE OF THE STYRENE POST DISTRIBUTION. THERE IS GEL RESIDUE EVIDENCE THAT THE APEX PAD WAS ADHERED TO THE COATED SIDE OF THE STYRENE PACKAGING. RETAINED SAMPLE TESTING WAS PERFORMED AND LOT 0822D WERE FOUND TO BE ASSEMBLED ACCORDING TO SPECIFICATION WITH NO DISCREPANCIES FOUND. THE ELECTRODE PADS WERE SCRAPPED. 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 TREAT A (B)(6)-YEAR-OLD MALE PATIENT, THE PADS WERE DAMAGED DURING OPENING/REMOVAL OF PACKAGING, CAUSING A DELAY IN THERAPY. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200282 CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES - ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0402 0822D 00847946016319

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male