BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFORMATION CENTER NETWORK DATABASE

    MDR report key: 1651009 · Received April 1, 2010

    Report

    Report Number
    1218950-2010-00425
    Event Type
    Death
    Date Received
    April 1, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED. THE CUSTOMER WAS INTERVIEWED FURTHER AND STATED THAT THE PATIENT HAD A WEAK HEART, AND THERE WAS NO ALLEGATION OR INDICATION THAT A DEVICE FAILURE OCCURRED. THEY WERE LOOKING FOR DATA IN ORDER TO FOLLOW UP PROCEDURALLY WITH HOW LONG IT TOOK THE MONITOR TECHS TO NOTIFY CARE GIVING STAFF OF THE ALARMS. THE ALARM LOGS WERE OBTAINED FROM THE CENTRAL STATION INVOLVED, AND THEY SHOW MULTIPLE ALARMS ANNUNCIATED FOR THIS PATIENT AND ACKNOWLEDGED (SILENCED) AT THE CENTRAL STATION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFORMATION CENTER NETWORK DATABASE MHX, DRT MHX PHILIPS MEDICAL SYSTEMS M3155B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death