BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOORE MEDICAL ADULT MULTI-FUNCTION ELECTRODES

    MDR report key: 2456421 · Received February 10, 2012

    Report

    Report Number
    1218058-2012-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 8, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K033771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT THE (B)(4) MULTI-FUNCTION ELECTRODES INVOLVED IN THIS REPORT ARE UNABLE TO BE RETURNED FOR EVAL. NO OTHER PT INFO BESIDES SEX WAS DISCLOSED TO BIO-DETEK. THE RETAIN SAMPLES OF LOT 1711 WERE EXAMINED. THE VISUAL EXAMINATION SHOWED THAT THERE WERE NO MFG DEFECTS AND THAT THE PRODUCT WAS MFG ACCORDING TO SPEC. THE RETAIN SAMPLES OF LOT 1711 WERE TESTED ACCORDING TO NORMAL QC RELEASE PROCEDURES. ALL RESULTS WERE WITHIN SPEC. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADD'L INFO FROM THE DISTRIBUTOR, (B)(4), AND FROM THE END USER, (B)(6). NO FURTHER INFO HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM AN END USER THAT DURING A RESCUE ATTEMPT ON A CARDIAC ARREST PT, A SHOCK WAS DELIVERED THAT DID NOT CAPTURE. CPR WAS PERFORMED. AN INTERRUPTED SIGNAL APPEARED ON THE MONITOR. A SECOND SHOCK WAS DELIVERED THAT APPEARED TO ARC WHERE A BURNT SMELL WAS DETECTED. CPR CONTINUED. THE MONITOR WAS CHANGED. A THIRD SHOCK WAS SUCCESSFULLY DELIVERED EN ROUTE TO THE HOSP. THE PT LATER EXPIRED. THE END USER WAS USING A LIFEPAK DEFIBRILLATOR WITH (B)(4) MULTI-FUNCTION ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOORE MEDICAL ADULT MULTI-FUNCTION ELECTRODES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-W) MKJ BIO-DETEK, INC. 83817 1711

    Patients

    Seq Age Sex Outcome Treatment
    1