BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3155 RELEASE L.0 UPGRADE

    MDR report key: 2091113 · Received May 6, 2011

    Report

    Report Number
    1218950-2011-01262
    Event Type
    Death
    Date Received
    May 6, 2011
    Report Date
    April 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PATIENT CODED BUT NO ALARM WAS PROVIDED AT THE PHILIPS INFORMATION CENTER (PIC). THE HOSPITAL STAFF DID NOT RESPOND IN A TIMELY MANNER AND THE PATIENT EXPIRED. THE CUSTOMER REQUESTED THAT LOGS BE REVIEWED TO UNDERSTAND WHAT OCCURRED. LOGS WERE PROVIDED AND ANALYZED. THE CUSTOMER STATED THAT THE CODE WAS INITIATED ON (B)(6) 2011, AT 22:19. BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS REPORT, THE LOGS SHOW THAT AN ALARM FOR BRADY 39<40 OCCURRED AT 22:12, WHICH WAS SILENCED AT THE CENTRAL STATION WITHIN 4 SECONDS. ANOTHER BRADY 39<40 OCCURRED AT 22:15, WHICH THEN ESCALATED TO ASYSTOLE AT 22:15. THIS ALARM WAS SILENCED AT THE CENTRAL STATION AT 22:19, WHICH IS THE TIME THE CODE WAS INITIATED. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT THERE WAS A MALFUNCTION, DESIGN OR LABELING PROBLEM. THE ALARMS WERE SILENCED BY THE CLINICIANS. DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES ALARM BEHAVIOR, RED AND YELLOW ALARMS, REMINDERS AND ALARM PRIORITY CHAINING. CONSIDERATION OF THIS COMPLAINT AND SIMILAR COMPLAINTS SUPPORTS THAT THERE IS NO DESIGN, MANUFACTURING, MATERIALS OR LABELING PROBLEM. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CENTRAL STATION DID NOT ALARM THEREFORE THEY DID NOT KNOW THAT A PT ON TELEMETRY HAD GONE INTO VTACH AND LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3155 RELEASE L.0 UPGRADE MHX PHILIPS HEALTHCARE M3155

    Patients

    Seq Age Sex Outcome Treatment
    1 Death