BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 4893534 · Received July 6, 2015

    Report

    Report Number
    3010617000-2015-00388
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON 06/24/2015 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE LI-ION BATTERY (S/N (B)(4)) WAS RETURNED TO ZOLL FOR EVALUATION ON (B)(4) 2015. INVESTIGATION RESULTS AS FOLLOWS: THERE WERE NO PHYSICAL DAMAGES OBSERVED DURING VISUAL EVALUATION. THE REPORTED COMPLAINT OF "BATTERY COULD NOT BE RECOGNIZED BY THE AUTOPULSE" WAS NOT CONFIRMED. THE BATTERY PASSED ALL TESTING CRITERIA. NO ISSUES WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A "REPLACE BATTERY" OR "RECHARGE BATTERY" MESSAGE WHEN AUTOPULSE LI-ION BATTERY WITH SERIAL NUMBER (SN) (B)(4) WAS INSTALLED INTO THE DEVICE. CUSTOMER INDICATED THAT THE BATTERY INDICATOR SHOWED THAT THE BATTERY WAS FULLY CHARGED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434708 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1