BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINICAL INFORMATION CENTER

    MDR report key: 1678228 · Received May 7, 2010

    Report

    Report Number
    2124823-2010-00044
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    March 31, 2010
    Report Date
    May 7, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K080251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATED THE REPORTED ISSUE. THE LOGS CONFIRM THAT NO ASYSTOLE EVENT WAS CALLED AT 07:06 FOR THE BED IN QUESTION ON (B) (6) 2010. HOWEVER, THE FOLLOWING CLINICAL ALARMS WERE CALLED AROUND THE TIME IN QUESTION: [2010-(B) (6)] 07:05:37 ADU ACC VENT. [2010-(B) (6)] 07:06:32 ADU V BRADY. [2010-(B) (6)] 07:07:24 ADU HR LO 41. [2010-(B) (6)] 07:07:29 ADU V BRADY. [2010-(B) (6)] 07:07:49 ADU HR LO 41. ECG (ELECTROCARDIOGRAM) EVENT HISTORY STRIPS FROM THE REPORTED TIME OF APPROX 7:06 AM SHOW AN ALARM FOR V-BRADY. THIS ALARM IS CONSISTENT WITH THE DEVICE CRITERIA OF A RHYTHM THAT CAN BE INTERPRETED AS VENTRICULAR ECTOPIC BEATS AT A RATE OF 50 BEATS PER MINUTE OR LESS. THREE SUBSEQUENT EVENT STRIPS (7:12 - 7:18 AM) SHOW ADD'L ALARMS FOR V-BRADY, PAUSE, AND ASYSTOLE. OF THESE INITIAL STRIPS, ONLY THE LAST EVENT STRIP (07:18:25) MEETS THE CRITERIA FOR AN ASYSTOLE ALARM; THE OTHER STRIPS STILL HAD CLEARLY DEFINE BEATS THAT WOULD HAVE PREVENTED THE COMPUTED HEART RATE FROM DROPPING TO ZERO (THE PRIMARY CRITERION FOR AN ASYSTOLE ALARM). FOUR ADD'L HISTORY EVENT STRIPS FROM APPROX 7:26 - 7:30 SHOW PRESUMED VENTRICULAR FIBRILLATION FOR WHICH THE MONITOR PROVIDED VFIB/VTACH OF VTACH ALARMS. NO MALFUNCTION IS INDICATED BY ANY OF THE DATA PROVIDED.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE CENTRAL STATION DID NOT ALARM FOR A PT IN ASYSTOLE. THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL INFORMATION CENTER CENTRAL MONITORING SYSTEM MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death