BEUDAMED
    FDA Adverse Event Death Summary report: N

    R2 MEDICAL

    MDR report key: 412935 · Received August 22, 2002

    Report

    Report Number
    412935
    Event Type
    Death
    Date Received
    August 22, 2002
    Date of Event
    August 17, 2002
    Report Date
    August 21, 2002
    Manufacturer
    R2 MEDICAL SYSTEMS, INC
    Product Code
    DSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 10/29/2002: THE USER FACILITY PROVIDED MODEL NUMBER 184-520X-01096. BALLARD MEDICAL DOES NOT IDENTIFY THE REPORTED MODEL NUMBER AS A VALID NUMBER. THEREFORE, BALLARD MEDICAL DETERMINED THE CORRECT CATALOG NUMBER TO BE 32-184520X. THE LOT NUMBER AND SERIAL NUMBER ARE NOT AVAILABLE. THE PT WAS ASYSTOLIC. THE USER TRIED TO PACE THE PT BUT THE CODE CART WOULD NOT PACE. THE USER CHANGED THE CART AND THEN THE PADS WITH NO SUCCESS. THE CABLE WAS CHANGED AND PACING WAS ACHIEVED. RESUSCITATION OF THE PT WAS NOT SUCCESSFUL. THE PT EXPIRED. BALLARD MEDICAL PRODUCTS SPOKE WITH REP OF HOSPITAL ON 10/28/2002 AND 10/29/2002. THE ONLY ADD'L INFO THEY COULD PROVIDE WAS THAT THE PT HAD A HISTORY OF HEART RELATED HEALTH PROBLEMS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BALLARD MEDICAL PRODUCTS WAS MADE AWARE OF THE EVENT ON 08/22/2002. ON THE DATE, THEY RECEIVED A PHONE CALL FROM THE USER FACILITY. BALLARD MEDICAL ALSO RECEIVED A FAXED COPY OF A MANDATORY MEDWATCH REPORT FROM THE USER FACILITY ON 08/22/2002. BALLARD MEDICAL PRODUCTS CONTACTED THE HOSPITAL, REGARDING RETURN OF THE DEVICE, INVOLVED IN THE INCIDENT. THE DEVICE IS BEING RETAINED BY RISK MGMT. BALLARD MEDICAL CONCLUDED THAT THEIR DEVICE WAS RELATED TO THE EVENT. BALLARD MEDICAL WAS UNABLE TO OBTAIN ANY ADD'L INFO REGARDING THE ACTUAL INCIDENT. THE DIRECTIONS FOR USE INSTRUCT THE USER TO CHECK BOTH THE CABLE CONNECTION AND ELECTRODE CONNECTION ENDS, OF THE ADAPTER, PRIOR TO USE AND TO NOT USE THE DEVICE IF THE CONNECTOR PINS ARE DAMAGED. THE DEVICE WAS IN USE FOR FOUR YEARS. BALLARD MEDICAL PROVIDES SERVICING FOR THEIR CABLE DEVICES. HOWEVER, A LOT NUMBER WAS NOT PROVIDED WITH THIS DEVICE AND CO COULD NOT DETERMINE WHEN OR IF THIS DEVICE WAS SERVICED.

    Description of Event or Problem · 1

    PT EXPERIENCED ASYSTOLE CODE EVENT. RESIDENTS WANTED PACING, CODE CART LP9P WOULD NOT PACE. CHANGED PADS, THEN CART WITH NO SUCCESS. CABLE CHANGED AND PACING WAS ACHIEVED. RESUSCITATION NOT SUCCESSFUL. PT EXPIRED 0530 HRS. FOUND FAULTY CONNECTION IN ADAPTER CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R2 MEDICAL HANDS FREE ADAPTER CABLE DSA R2 MEDICAL SYSTEMS, INC 184-520X-01096 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death