BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYS MODEL 100

    MDR report key: 2934675 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00613
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MED CORPORATION HAS NOT YET REC'D THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING WEEKLY CHECK, UNIT STOPPED WORKING AND DISPLAYED "FANS ARE BLOCKED" AFTER ABOUT 4 CYCLES. CUSTOMER STATED THAT THE FAN WAS NOT BLOCKED. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYS MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other