BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943520 · Received January 9, 2013

    Report

    Report Number
    3003793491-2012-00593
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO THE MANUFACTURER DID NOT INDICATE A POTENTIAL SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE MANUFACTURER ON (B)(4) 2012 AND ANALYZED. THE CUSTOMER'S INITIAL COMPLAINT OF SYSTEM ERROR-OUT OF SERVICE WAS VERIFIED. THE PROCESSOR BOARD WAS OBSERVED TO BE AT FAULT AND WAS SUBSEQUENTLY REPLACED. IT WAS ALSO OBSERVED THAT THE TOP COVER WAS CRACKED, THE MOTOR COVER DAMAGED AND DEVICE WAS MISSING BATTERY PARTITION COVER. THE TOP COVER AND MOTOR COVER WERE REPLACED. A NEW BATTERY PARTITION COVER WAS ALSO INSTALLED TO THE UNIT. NO ISSUES WERE EXHIBITED IN THE ARCHIVE. BOARD PASSED FINAL TEST. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE ASSOCIATED WITH A FAULT PROCESSOR BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AUTOPULSE RESUSCITATION SYSTEM S/N (B)(4) EXPERIENCED A SYSTEM ERROR/OUT OF SERVICE. THIS ERROR CODE APPEARED DURING PATIENT USE. HOWEVER NO PATIENT INFORMATION IS AVAILABLE. MANUAL CPR WAS INITIATED. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11172 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other