BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 245859 · Received October 20, 1999

    Report

    Report Number
    1824226-1999-00001
    Event Type
    Injury
    Date Received
    October 20, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 9, 1999
    Manufacturer
    KING SYSTEMS CORP
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR WAS NOTIFIED ON 8/9/1999 THAT A SERIOUS INCIDENT HAD OCCURRED DURING THE PRIOR WEEKEND. RISK MANAGEMENT DEPT AT THE HOSP HAS NOT ALLOWED MFR REP TO EXAMINE THE BREATHING CIRCUIT BEING USED AT THE TIME OF THE ALLEGED INCIDENT, NOR PROVIDED INFO NEEDED FOR A PROPER REPORT. A VOLUNTARY REPORT WAS FILED BY MFR TO THE FDA ON 9/7/1999, VIA TELEPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CAI KING SYSTEMS CORP D 346R-6133 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR