BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 2153253 · Received June 30, 2011

    Report

    Report Number
    2124823-2011-00102
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 30, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DSI
    PMA / PMN Number
    K062976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TELEMETRY PT'S DATA WAS INADVERTENTLY REPLACED ON SCREEN WITH ANOTHER TELEMETRY PT AT THE CENTRAL STATION BY THE USER. NO MALFUNCTION WAS OBSERVED. AT THIS TIME, THE SECOND (DISPLAYED) PT EXPERIENCED AFIB ARRHYTHMIA, BUT THE ORIGINAL (REPLACED) PT WAS ADMINISTERED MEDICATION BEFORE THE DISPLAY ASSIGNMENT ERROR WAS NOTICED. BOTH PTS RECOVERED WITHOUT FURTHER INCIDENT. THE REPLACEMENT OF THE ORIGINAL PT'S DATA ON THE CLINICAL INFORMATION CENTER (CIC) SCREEN MAY HAVE CONTRIBUTED TO CAREGIVER CONFUSION, WHICH RESULTED IN IMPROPER TREATMENT OF THE WRONG PT. THERE WAS NO DEATH ASSOCIATED WITH THIS EVENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL STATION DSI GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other