BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M¿ RED DOT¿ MONITORING ELECTRODES

    MDR report key: 8160628 · Received December 13, 2018

    Report

    Report Number
    2110898-2018-00112
    Event Type
    Death
    Date Received
    December 13, 2018
    Date of Event
    November 11, 2018
    Report Date
    December 13, 2018
    Manufacturer
    3M HEALTH CARE
    Product Code
    DRX
    UDI-DI
    10707387499966
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED. ACTUAL DEVICE USED IN THIS REPORT WAS NOT AVAILABLE FOR ANALYSIS. CUSTOMER PROVIDED LOT NUMBER 2020 10 FH WHICH WAS FOUND IN THE UNIT. IT WAS UNKNOWN IF THIS WAS THE SAME LOT NUMBER OF THE ELECTRODES USED IN THIS EVENT. CUSTOMER STATED SAMPLES FROM THE SAME STOCK WOULD BE SENT TO 3M FOR ANALYSIS. SAMPLES HAVE NOT BEEN RECEIVED TO DATE. CONCOMITANT MEDICAL PRODUCTS: PHILLIPS HEART START MRX DEFIBRILLATOR LEAD WIRES. 3M RECEIVED INFORMATION FROM TWO REPORTERS AT THE FACILITY. INFORMATION FROM BOTH REPORTERS WAS PROVIDED IN THIS REPORT. MEDWATCH (B)(4) WAS RECEIVED ON 11DEC2018 FROM THE FDA. ALTHOUGH THE FACILITY REPORTED THERE WAS NO ASSOCIATION OR FINDINGS THAT THE PATIENT DEATH WAS RELATED TO THE INCIDENT IN THIS COMPLAINT, 3M IS SUBMITTING THIS MDR REPORT BECAUSE A PATIENT DEATH REPORTEDLY OCCURRED. RETAINED SAMPLES OF THE ELECTRODES FROM THIS LOT NUMBER WERE TESTED AND MET SPECIFICATIONS. END OF REPORT.

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT IN ICU EXPERIENCED A SLIGHT DELAY WITH AN URGENT CARDIOVERSION WHEN 2670-5 RED DOT ELECTRODE STUBS WERE FOUND STUCK IN THE DEFIBRILLATOR LEAD WIRES FROM A PREVIOUS USE. THE SLIGHT DELAY OCCURRED WHEN THE STAFF OBTAINED ANOTHER DEFIBRILLATOR FROM THE UNIT FOR THE CARDIOVERSION. THE PATIENT IN THIS REPORT LATER EXPIRED. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S MEDICAL CONDITION/DIAGNOSIS, TIME OF THE INCIDENT OR TIME OF THE PATIENT DEATH. THE NURSE REPORTED THERE WAS NO ASSOCIATION OR FINDINGS THAT THE PATIENT DEATH WAS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001951 3M¿ RED DOT¿ MONITORING ELECTRODES ECG ELECTRODE DRX 3M HEALTH CARE N/A 2020 10 FH 10707387499966

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death LEAD WIRES