BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3250980 · Received July 29, 2013

    Report

    Report Number
    3003793491-2013-00755
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 3, 2013
    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

    ZOLL CIRCULATION HAS RECEIVED THE PRODUCT IN COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED FOR EVALUATION AND IT CONFIRMED THE REPORTED PROBLEM. THE ARCHIVE DATA ANALYSIS EXHIBITED USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE). THE LOAD CELL CHARACTERIZATION TESTING CONFIRMED THE LOAD CELL MODULE WAS NOT FUNCTIONING PROPERLY. THE LOAD CELL MODULE WAS REPLACED AND THE PLATFORM PASSED TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT, USE THE AUTOPULSE RESUSCITATION SYSTEM DISPLAYED A USER ADVISORY UA07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. CUSTOMER ATTEMPTED TO USE A NEW LIFEBAND AND ERROR CODE WOULD NOT CLEAR. CUSTOMER ALSO INDICATED THAT THERE DID NOT APPEAR TO BE AN ISSUE WITH PATIENT POSITIONING. NO PATIENT INFORMATION IS AVAILABLE AND NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354058 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1