BEUDAMED
    FDA Adverse Event Death Summary report: N

    R2 MULTIFUNCTION DEFIB PAD

    MDR report key: 1367939 · Received April 21, 2009

    Report

    Report Number
    1317214-2009-00033
    Event Type
    Death
    Date Received
    April 21, 2009
    Date of Event
    March 24, 2009
    Report Date
    April 20, 2009
    Manufacturer
    AVENT S.A. DE R.L. DE C.U.
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED CORP. ACQUIRED THESE DEVICES FROM KIMBERLY-CLARKE. HOWEVER, BY FORMAT OF THE LOT CODE WE KNOW THIS PRODUCT WAS NOT MANUFACTURED BY CONMED. THIS PRODUCT WAS MANUFACTURED BY: AVENT S.A. DUE TO THE ACQUISITION, CONMED HAS RESPONSIBILITY FOR FILING COMPLAINTS IN THE FIELD, HOWEVER, THIS PRODUCT WAS MADE BY AVENT S.A. DE R.L. DE C.U. FOR KIMBERLY CLARKE PRIOR TO THE ACQUISITION. WE ARE ATTEMPTING TO GATHER ADDITIONAL INFORMATION REGARDING THIS INCIDENT. THE ACTUAL DEVICE WAS DISCARDED. WHEN THE QUALITY ENGINEER HAS COMPLETED THE INVESTIGATION, WE WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "WE WERE DISPATCHED TO A DIFF BREATHING FOR ONE OF OUR NEIGHBOR STATIONS. ARRIVED ON SCENE AND PT WAS CODE BLUE. BEGAN CPR AND PLACED PT ON MONITOR. ATTEMPTED TO SHOCK PT (SHE WAS IN V-TACH, NO PULSE) THE MONITOR WOULD NOT SHOCK, AND REPEATED ATTEMPTS WERE UNSUCCESSFUL, AND KEPT APPEARING "STOCK HALTED". ON THE MONITOR STRIP AT THE TOP OF THE TAPE PRINTED "PAD SHORTAGE ANALYZE HALTED". REMOVED PADS AND PLACED A SET OF DIFFERENT PADS FROM ANOTHER DISTRIBUTOR, AND MONITOR/PADS WORKED FINE. PT STATUS IS "DECEASED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R2 MULTIFUNCTION DEFIB PAD DEFIB PAD MLN AVENT S.A. DE R.L. DE C.U. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death ZOLL BRAND MONITOR