BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

    MDR report key: 9088601 · Received September 19, 2019

    Report

    Report Number
    1218058-2019-00134
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946000189
    PMA / PMN Number
    K011541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE ELECTRODE PADS AND THE CUSTOMER REPORT WAS NOT CONFIRMED. VISUAL INSPECTION FOUND DAMAGE TO THE PADS, AS WELL AS HAIR AND DEBRIS, INDICATING THAT THEY HAD BEEN PREVIOUSLY REMOVED FROM THE STYRENE LINERS AND PLACED BACK ON THE NON COATED SIDE OF THE STYRENE LINER. BASED ON THE RECEIVED CONDITION OF THE ELECTRODES, WE ARE UNABLE TO DETERMINE IF THE DAMAGE IS THE RESULT OF REAPPLICATION OR REMOVAL OF THE ELECTRODES FROM THE ORIGINAL PACKAGING. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS TORE APART WHEN THE PACKAGING WAS OPENED, WHICH PREVENTED THE ELECTRODES FROM BEING USED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884654 CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0800-01 0319 00847946000189

    Patients

    Seq Age Sex Outcome Treatment
    1