BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT PADZ HVP MULTI FUNCTION ELECTRODES

    MDR report key: 8497402 · Received April 9, 2019

    Report

    Report Number
    1218058-2019-00029
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEWING DETAILS FROM THE CUSTOMER DURING AN ONSITE VISIT AND PHOTOGRAPHS OF THE AREAS OF CONCERN ON THE PATIENT, ZOLL BELIEVES THAT THE PATIENT'S SKIN IRRITATIONS REPORTED WERE MORE LIKELY TO BE A SKIN BURN AFTER 24 HOURS OF PAD PLACEMENT ON THE PATIENT. THE LOCATION OF BURNS INDICATED POOR PAD PLACEMENT (BURNS LOCATED IN OR AROUND THE PATIENT'S ARMPITS). NO DEFIBRILLATIONS OR PACING WERE PERFORMED ON THIS PATIENT. THE INSTRUCTIONS FOR USE PROVIDES DIAGRAMS AND SPECIFIC INSTRUCTIONS ON GOOD PLACEMENT AND WARNS AGAINST PLACING PADS OF FOLDS OF SKIN. ELECTRODE LABELING ALSO PROVIDES INSTRUCTION FOR PROPER ELECTRODE APPLICATION TECHNIQUE. POOR ADHERENCE AND/OR AIR UNDER THE ELECTRODES CAN LEAD TO THE POSSIBILITY OF ARCING AND SKIN BURNS. GOOD SKIN PREPARATION DOES NOT GUARANTEE A BURN WILL NOT OCCUR. THE ELECTRODE PADS WERE NOT AVAILABLE FOR EVALUATION. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 (B)(6) FEMALE PATIENT, AFTER A 24 HOUR PLACEMENT OF THE ELECTRODE PADS ON THE PATIENT, UPON REMOVAL OF THE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT DID NOT INDICATE IF ADDITIONAL TREATMENT FOR THE BURNS SUSTAINED WERE REQUIRED. PLEASE REFERENCE MEDWATCH REPORT 1220908-2019-00027 AND 1220908-2019-00028 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288228 STAT PADZ HVP MULTI FUNCTION ELECTRODES DEFIB/PACING ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4004 UNK 00847946016456

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other