BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3063003 · Received March 26, 2013

    Report

    Report Number
    3003793491-2013-00339
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "BATTERY SHOWED A FULL CHARGE, BUT WHEN PLACED IN THE PLATFORM, THE PLATFORM INDICATED THAT THE BATTERY VOLTAGE WAS TOO LOW" WAS CONFIRMED. IT WAS ALSO NOTED THAT THE PLATFORM POWERS ON BY ITSELF WHEN THE BATTERY IN INSERTED AND SHUTS OFF DURING COMPRESSION WITH THE LARGE RESUSCITATION TEST FIXTURE. POWER DISTRIBUTION BOARD WAS FOUND TO BE AT FAULT, IT WAS REPLACED. ARCHIVE FILE SHOWED THAT THERE WERE TWO SESSIONS WHERE THE PLATFORM SHUT DOWN DURING COMPRESSION. ARCHIVE FILE ALSO SHOWED THAT USER ADVISORY 18 (MAX TAKE-UP REVOLUTION EXCEEDED) AND USER ADVISORY 45 (NOT AT "HOME" POSITION HAD OCCURRED. THE PLATFORM DID NOT SHOW ANY VISIBLE SIGNS OF DAMAGE. THE PLATFORM PASSED THE FINAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO USE A BATTERY THAT SHOWED FULLY CHARGED, BUT WHEN PLACED IN THE PLATFORM, THE PLATFORM INDICATED THAT THE BATTERY VOLTAGE WAS TOO LOW AND PROMPTED THE USER TO REPLACE THE BATTERY. BATTERY WAS REPLACED, PLATFORM OPERATED AS EXPECTED. THE BATTERY THAT WAS INITIALLY USED WAS LATER PLACED IN THE PLATFORM, THIS TIME IT WORKED. BATTERY SN (B)(4) AND THE PLATFORM WILL BE RETURNED. ZOLL REPRESENTATIVE CHECKED THE BATTERY ARCHIVE FILE, IT INDICATED THAT THE BATTERY HAD NOT BEEN PLACED IN THE CHARGER BUT IT INDICATED THAT IT WAS FULLY CHARGED. NO ADDITIONAL INFORMATION COULD BE OBTAINED. THERE WAS NO PT SEQUELA REPORTED. AUTOPULE PLATFORM MFR REPORT #: 3003793491-2013-00339. LI-ION BATTERY MFR REPORT #: 3003793491-2013-00338.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123044 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other