BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 3130991 · Received May 13, 2013

    Report

    Report Number
    3003793491-2013-00542
    Event Type
    Death
    Date Received
    May 13, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE NICKEL METAL HYDRIDE (NIMH) BATTERY WAS RETURNED TO ZOLL ON (B)(4) 2013 FOR INVESTIGATION. EVALUATION OF THE RETURNED BATTERY CONFIRMED THE REPORTED COMPLAINT. THE RECEIVED BATTERY FAILED TESTING. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET REC'D THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS REC'D AND EVALUATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON THE MORNING OF (B)(6) 2013, THE CREWS PULLED TWO AUTOPULSE BATTERIES OUT OF THE BEIGE CHARGER AND PUT ONE INTO THE DEVICE AND THE OTHER IN THE BATTERY POUCH IN THE CARRYING CASE. LATER THAT DAY, THE CREW RESPONDED TO (B)(6) MALE PT HAVING A CARDIAC ARREST. THE AUTOPULSE PLATFORM WAS USED. THE CREWS REPORTED THAT THE FIRST BATTERY LASTED IN THE DEVICE FOR APPROXIMATELY "5 MINUTES" AND THE PLATFORM PROMPTED THEM TO CHANGE BATTERIES. THE BATTERY WAS CHANGED TO THE ONE PLACED IN THE CARRYING CASE THAT MORNING. THIS BATTERY LASTED APPROXIMATELY "10 MINUTES" WHICH WAS HOW LONG TRANSPORT TO THE HOSPITAL LASTED. THE PT WAS PRONOUNCED DEAD AT THE HOSPITAL. THE CAUSE OF DEATH WAS NOT PROVIDED. THE CUSTOMER STATED THAT AN AUTOPSY REPORT WOULD BE DIFFICULT TO OBTAIN UNLESS YOU ARE A FAMILY MEMBER. IT WOULD BE THROUGH THE (B)(4) DEPARTMENT OF HEALTH. THE CUSTOMER ALSO STATED THAT THE AUTOPULSE BATTERIES WERE FAILING. THE BATTERY LASTS FIVE MINUTES OR LESS AND THE BATTERY CHARGER IS SAYING GREEN LIGHT AND FULLY CHARGED. THEY STATED THAT THE CREW IS FOLLOWING THE BATTERY ROTATION SCHEDULE. THE CUSTOMER ADDED THAT WHEN THEY RECEIVE NEW BATTERIES, EACH ONE IS PLACED ON THE CHARGER TO ASSURE THEM THAT THE BATTERIES ARE NOT ONLY FULLY CHARGED BUT ARE ALSO LOAD TESTED BY THE CHARGER TO ENSURE PROPER WORKING ORDER. THE REPORTER WAS NOT AWARE OF ANY PROBLEMS WITH THE INITIAL CHARGING OF THE BATTERIES. HE INFORMED THAT THEY RUN 4 BATTERIES WITH EACH AUTOPULSE AND THE TWO THAT ARE NOT IN THE CHARGER ARE EITHER IN THE DEVICE OR IN THE BAG. HE STATED THAT AS SOON AS THE BATTERIES ARE REC'D, THEY GO INTO THE CHARGER, SO THAT THEY ARE AVAILABLE FOR USE. FURTHER INFO WAS REC'D BY CUSTOMER INDICATING THAT THE CREW IS UNAWARE OF WHICH BATTERY FAILED AT WHICH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211732 AUTOPULSE NIMH BATTERY AUTOPULSE NIMH BATTERY DRM ZOLL CIRCULATION, INC 8700-0702-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death