BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M DEFIB PADS

    MDR report key: 6896056 · Received September 26, 2017

    Report

    Report Number
    2110898-2017-00130
    Event Type
    Death
    Date Received
    September 26, 2017
    Date of Event
    August 24, 2017
    Report Date
    October 2, 2017
    Manufacturer
    3M INFECTION PREVENTION
    Product Code
    GYB
    UDI-DI
    30707387284733
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS NOT INCLUDED IN THE INITIAL REPORT. A STATEMENT FROM THE BIOMEDICAL ENGINEER OF THE HOSPITAL INDICATES TESTING WAS CONDUCTED ON ALL ITEMS AND WORKED IN THE CORRECT WAY. THE METHOD BIOMEDICAL ENGINEER USED TO EVALUATE THE DEFIB PADS WAS NOT SPECIFICALLY STATED. THE ASSUMPTION IS THE TESTING WAS A VISUAL FOR WETNESS. HOWEVER, ALL PRODUCTION DATA FROM LOT 2018-11AU APPLIES TO MODEL 2345N WAS REVIEWED. ALL PRODUCTION DATA WAS NORMAL AND THERE WERE NO NCNS FOR ISSUES RECORDED DURING THE RUN OF THIS LOT. ALL RELEASE TESTING OF THIS LOT PASSED ALL SPECIFICATIONS. DATA FROM THE COATING STEP OF THIS LOT WAS REVIEWED AS WELL, AND ALL DATA WAS WITHIN SPECIFICATION WITH NO RECORDED NONCONFORMANCES. A TOTAL OF SIX RETAINS SAMPLES WERE EXAMINED FROM LOT 2018-11AU. ALL 6 RETAINS WERE TESTED FOR IMPEDANCE AND ALL 6 SAMPLES WERE WITHIN SPECIFICATION. END OF REPORT.

    Additional Manufacturer Narrative · 1

    NO TITLE OF THE INITIAL REPORTER WAS PROVIDED. THIS COMPLAINT IS LINKED TO 2110898-2017-00131. SINCE A DIFFERENT PRODUCT WAS USED AND REPLACED THE PRODUCT USED UNDER THIS COMPLAINT. PRODUCT HAS BEEN SHIPPED TO 3M FOR EVALUATION BUT NOT RECEIVED YET FOR EVALUATION. IT WAS NOTED THE PADS LOOKED NORMAL AND WERE WET. END OF REPORT

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: APPLICATION OF A FIRST SET OF PATCHES (2345N) WAS PLACED ONTO THE PATIENT AND TWO EXTERNAL SHOCKS USING THE SAME DEFIBRILLATOR WAS GIVE TO THE PATIENT. NO SIGN OF CONDUCTION. ANOTHER SET OF PADS WERE APPLIED USING A DIFFERENT MODEL NUMBER.

    Description of Event or Problem · 1

    A MALE PATIENT IN CARDIAC ARREST UNDERWENT DEFIBRILLATED USING 3M DEFIB PADS (CONSISTING OF ELECTRO CONDUCTIVE GEL). THERE WAS NO SIGN OF ELECTRIC CONDUCTIVITY DURING INITIAL DEFIBRILLATION NOR A RESPONSE FROM THE PATIENT. THE 3M DEFIB PADS WERE REMOVED AND REPLACED WITH NEW SET AND DIFFERENT CATALOG NUMBER. PATIENT SUBSEQUENTLY DIED. IT WAS CONFIRMED THE DEFIBRILLATOR USED WITH THESE SPECIFIC DEFIBS PADS WORKED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674282 3M DEFIB PADS CONDUCTIVE GEL GYB 3M INFECTION PREVENTION N/A 2018-11 AU 30707387284733

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death