BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR (AA) ELECTRODES

    MDR report key: 1881312 · Received October 18, 2010

    Report

    Report Number
    1220908-2010-02913
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONESTEP CPR (AA) ELECTRODES ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0217-XX 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA