BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M DEFIB PADS

    MDR report key: 6896043 · Received September 26, 2017

    Report

    Report Number
    2110898-2017-00131
    Event Type
    Death
    Date Received
    September 26, 2017
    Date of Event
    August 24, 2017
    Report Date
    October 3, 2017
    Manufacturer
    3M INFECTION PREVENTION
    Product Code
    LDD
    UDI-DI
    30707387284740
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO LOT NUMBER GIVEN NOR WAS THE PRODUCT USED RETURNED. IT IS DIFFICULT TO REVIEW PRODUCT RELEASE DATA TO MAKE SURE PRODUCT INVOLVED IN THE REPORTED INCIDENT MET ALL ITS RELEASE CRITERIA. BASED ON REVIEW OF COMPLAINTS FOR TWO YEARS THERE HAS ONLY BEEN ONE REPORT OF THIS TYPE OF EVENT FOR THIS SPECIFIC MODEL AND IT IS THIS ONE BEING SUBMITTED TO FDA. HOWEVER, THE HOSPITAL BIOMED ENGINEER INDICATED THE HARDWARE INCLUDING DEFIB PADS WERE EXAMINED AND FUNCTIONED IN THE CORRECT WAY. THE METHOD USED WAS NOT DISCLOSED BUT THE ASSUMPTION IS THEY MAY HAVE PERFORMED A VISUAL AND TOUCH FOR WETNESS REGARDING THE DEFIB PADS. THIS REPORT IS LINKED TO 2110898-2017-00130 FOR IT INVOLVED THE SAME PATIENT BUT THE USE OF A DIFFERENT MODEL PRODUCT AND ONE THAT DID INCLUDE A SPECIFIC REPORTED LOT NUMBER. THE EVIDENCE OF THAT COMPLAINT CONFIRM PRODUCT MET SPECIFICATION AND WAS CONDUCTIVE. END OF REPORT.

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED. WITHOUT LOT NUMBER YOU CAN NOT DETERMINE EXPIRATION DATE OR MANUFACTURER DATE. THIS COMPLAINT IS LINKED TO 2110898-2017-00130. SINCE A DIFFERENT PRODUCT WAS USED AND REPLACED THE PRODUCT USED UNDER THIS COMPLAINT. 2110898-2017-00130 USED 2345N AND THIS COMPLAINT 2110898-2017-00131 USED 2346N. THE PATIENT WAS THE SAME. THE INFORMATION RECEIVED INDICATED FOUR SHOCKS WERE GIVE WITHIN 20 MINUTES BUT IT WAS NOT CLEAR HOW MANY SHOCKS USED 2345N AND 2346N. PRODUCT 2345N UNDER THIS COMPLAINT WAS NOT RETURNED. THIS IS A VERY RARE OCCURRENCE AND EVENT. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    NEW INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS GIVEN TWO SHOCKS USING THE SAME PADS WITH TWO DIFFERENT DEFIBRILLATORS.

    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 SECOND OR THIRD DEFIBRILLATION NOR A RESPONSE FROM THE PATIENT. PATIENT SUBSEQUENTLY DIED. IT WAS CONFIRMED THE DEFIBRILLATORS USED WITH THESE SPECIFIC DEFIBS PADS WORKED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673089 3M DEFIB PADS CONDUCTIVE GEL LDD 3M INFECTION PREVENTION N/A UNK 30707387284740

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death