BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 3760209 · Received April 18, 2014

    Report

    Report Number
    3003793491-2014-00202
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON 04/21/2014 FOR INVESTIGATION. INVESTIGATION RESULTS 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.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE MULTI-CHEMISTRY CHARGER INDICATED THAT THE AUTOPULSE LI-ION BATTERY WAS FULLY CHARGED; HOWEVER, ONLY 3 LIGHT-EMITTING DIODES (LEDS) ARE LIT WHEN THE STATUS CHECK BUTTON IS PRESSED ON THE BATTERY. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237431 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION, INC 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1