BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® LI-ION BATTERY

    MDR report key: 4210346 · Received October 29, 2014

    Report

    Report Number
    3010617000-2014-00571
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ZOLL CIRCULATION
    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

    ZOLL HAS NOT YET RECEIVED THE AUTOPULSE BATTERY IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON 10/31/2014 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 BATTERY'S ARCHIVE WAS ALSO PERFORMED AND IT WAS DETERMINED THAT THE BATTERY PERFORMED AS INTENDED. THERE WERE NO ISSUES OBSERVED WITH THE RETURNED BATTERY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED USER ADVISORY 41 DISPLAYED BY THE PLATFORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A FAULT 41 (PATIENT TEMPERATURE SENSOR FAILURE) WHILE USING AUTOPULSE LI-ION BATTERY WITH SERIAL NUMBER (SN) (B)(4). CUSTOMER PUT ANOTHER BATTERY INTO THE PLATFORM AND THE FAULT DID NOT REOCCUR. CUSTOMER ALSO REPORTED THAT THE INITIAL BATTERY (SN: (B)(4)) WOULD NOT CHARGE AND INDICATED THAT THERE WERE 3 AMBER LED LIGHTS LIT ON THE BATTERY WHEN THE STATUS CHECK BUTTON WAS PRESSED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692375 AUTOPULSE® LI-ION BATTERY LI-ION BATTERY DRM ZOLL CIRCULATION 8700-0752-01

    Patients

    Seq Age Sex Outcome Treatment
    1