BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 3831287 · Received May 23, 2014

    Report

    Report Number
    3003793491-2014-00261
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE BATTERY WAS OK WHEN THE CREW PLACED IT INTO THE PLATFORM AT SHIFT CHANGE. CUSTOMER CHECKED THE BATTERY AGAIN ON (B)(6) 2014. THE CHARGER SHOWED THAT THE BATTERY WAS FULLY CHARGED. IN ADDITION, 4 GREEN LED LIGHTS WERE LIT WHEN THE STATUS CHECK BUTTON WAS PRESSED. CUSTOMER TOOK THE CHARGED BATTERY AND PLACED IT INTO THE SAME PLATFORM THAT WAS USED ON THE CALL. THE BATTERY CHARGE STATUS ICON DISPLAYED 4 BARS ON THE PLATFORM'S DISPLAY SCREEN. THE PLATFORM RAN FOR 16 MINUTES WITH A MANNEQUIN, THEN STOPPED AND DISPLAYED A USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) MESSAGE. THE PLATFORM WAS RESTARTED AND RAN FOR ANOTHER 5 MINUTES. AGAIN, THE PLATFORM STOPPED AND DISPLAYED ANOTHER UA 2 MESSAGE. CUSTOMER RESTARTED THE PLATFORM, WHICH RAN FOR ANOTHER 16 MINUTES WITHOUT ISSUES. THERE WAS 1 BAR LEFT ON THE DISPLAY SCREEN ICON AFTER THIS 37 MINUTE TEST. THE PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED. PLEASE SEE RELATED MFR. REPORT #3003793491-2014-00262 FOR AUTOPULSE RESUSCITATION SYSTEM MODEL 100 WITH SN: UNKNOWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS FOR THE RETURNED BATTERY AS FOLLOWS: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. THE BATTERY PASSED ALL TESTING CRITERIA. A REVIEW OF THE ARCHIVE WAS ALSO PERFORMED AND IT WAS DETERMINED THAT THE BATTERY PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC ARREST CALL, THE AUTOPULSE LI-ION BATTERY WORKED FINE FOR LESS THAN 10 SECONDS AND THEN ABRUPTLY DEPLETED. THE AUTOPULSE PLATFORM SHUT DOWN AND COULD NOT BE RESTARTED. CUSTOMER SWITCHED TO A NEW BATTERY AND THE PLATFORM WORKED FINE FOR THE DURATION OF THE CALL. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308849 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR