BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000023-1999-00075

    MDR report key: 265897 · Received November 12, 1999

    Report

    Report Number
    6000023-1999-00075
    Event Type
    Malfunction
    Date Received
    November 12, 1999
    Date of Event
    June 28, 1999
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE TESTED OUT OF SPECIFICATION DURING MFGR'S ANALYSIS. DEVICE HAD ORIGINALLY BEEN RETURNED FOR EOL AND PATIENT HAD FELT SHOCK THERAPY.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other