BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2881784 · Received November 7, 2012

    Report

    Report Number
    3003793491-2012-00274
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF BOARD STOPPED COMPRESSION WITH 3 BATTERIES WAS NOT VERIFIED. RETURNED BATTERIES WERE TESTED, ALL HAD A POWER RATING BELOW THE 1300 WATT PASSING LEVEL. THEREFORE, THE LIKELY CAUSE FOR THE REPORTED EVENT IS THE USE OF BATTERIES THAT DID NOT MEET POWER LEVEL SPECS. ZOLL BATTERY MAINTENANCE PROGRAM INDICATES THAT EACH BATTERY SHOULD BE TEST-CYCLED A MINIMUM OF ONCE A MONTH TO MAINTAIN OPTIMAL PERFORMANCE AND REMOVED FROM THE BOARD AT THE END OF EACH SHIFT TO AVOID LOSS OF POWER. BATTERIES INVOLVED IN THE REPORTED EVENT (SERIAL #'S (B)(4)) WERE NOT MAINTAINED PROPERLY. FOR EXAMPLE, BATTERY IDENTIFIED WITH SERIAL # (B)(4) HAD A GAP OF 3 MONTHS BETWEEN THE 5TH AND THE 6TH TEST CYCLES AND ANOTHER 3 MONTHS BETWEEN THE 6TH AND THE 7TH TEST CYCLES. BATTERIES IDENTIFIED WITH SERIAL #'S (B)(4) HAD SIMILAR GAPS BETWEEN TEST CYCLES. FURTHERMORE, ARCHIVE FILE INDICATED THAT THERE WERE TIMES WHEN BATTERIES WERE LEFT IN THE BOARD, WHICH CAUSES THEM TO DRAIN AND SHORTENS THEIR RUN TIME. MOREOVER, THE ARCHIVE FILE RECORDED INSTANCES WHERE BATTERIES WERE PULLED OUT OF THE BOARD BEFORE THE SYSTEM WAS SHUT DOWN. THIS PRACTICE WHEN DONE ON A CONTINUOUS BASIS CAN DAMAGE THE POWER SUPPLY, WHICH IN TURN, CAN REDUCE BATTERY RUN TIME. BASED ON THIS EVAL, THE LIKELY CAUSE FOR THE REPORTED EVENT IS THE USE OF BATTERIES THAT WERE NOT PROPERLY MAINTAINED AND/OR FULLY CHARGED. INFO CONCERNING THE CONDITION OF THE PT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PT WITH FULL ARREST, THE BOARD STOPPED WORKING WITHOUT ANY WARNING. A SECOND AND THIRD BATTERY WAS USED WITH THE SAME RESULT. CUSTOMER INDICATED THAT DURING CHARGING, THE BATTERY CHARGER'S GREEN LIGHT HAD COME ON AND THAT THE BATTERIES WERE MAINTAINED ACCORDING TO ZOLL GUIDELINES. THIS REPORT PERTAINS TO THE AUTOPULSE NIMH BATTERIES. AUTOPULSE RESUSCITATION SYSTEM INVOLVED IN THIS CASE IS DISCUSSED IN REPORT #3003793491-2012-00273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other