BEUDAMED
    FDA Adverse Event Death Summary report: N

    PART OF PHILLIPS M3150A VIRIDIA (KAYAK XA400 PC)

    MDR report key: 495307 · Received October 31, 2003

    Report

    Report Number
    495307
    Event Type
    Death
    Date Received
    October 31, 2003
    Date of Event
    October 19, 2003
    Report Date
    October 31, 2003
    Manufacturer
    *
    Product Code
    DRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHILLIPS MODEL M3150A VIRIDA TELEMETRY SYSTEM INSTALLED PER MANUFACTURE INSTRUCTION WITH SERVERS AND KAYAK UNITS ON UNINTERRUPTED POWER SUPPLY (UPS) AND POWERED BY HOSPITAL EMERGENCY POWER. TELEMETRY SYSTEM MONITORS ON EMERGENCY POWER BUT NO UPS PER MANUFACTURE INSTALLATION OPTION. PATIENT ADMITTED WITH DIAGNASIS OF GI BLEED PLACED ON CARDIAC MONITOR, DUE TO CARDIAC HISTORY. HOSPITAL MOMENTARILY SHIFTED TO EMERGENCY POWER DUE TO POWER LOSS IN COMMUNITY. TELEMETRY SERVERS AND KAYAK UNITS REMAINED BOOTED AND FUNCTIONAL. ALL THREE TELEMETRY MONITORS FAILED WITH POWER SUPPLY UNITS HAVING TRIPPED THEIR RESET SWITCHES. DURING FAILURE PERIOD (MEDICAL ENGINEER WAS CALLED TO RESET/RECONNECT MONITORS TO KAYAK UNITS), THE PT WENT INTO UNDETECTED CARDIAC ARREST AND EXPIRED PRIOR TO STAFF DISCOVERING PATIENT'S CONDITION.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 2/24/04: MODEL NUMBER: M3150A. THE SERIAL NUMBERS PROVIDED BY THE CUSTOMER WERE FOR THE POWER SUPPLIES, NOT THE VIRIDIA INFORMATION CENTER. THE HOSPITAL BIOMED WAS UNABLE TO PROVIDE THE SPECIFIC SERIAL NUMBER. THE CUSTOMER NOTIFIED PHILIPS ON NOVEMBER 5, 2003. THE CUSTOMER REPORTED THAT DUE TO A POWER LOSS IN THE COMMUNITY THE HOSPITAL SHIFTED TO GENERATOR POWER. UPON REALIZATION OF THE POWER LOSS, THE NURSES NOTICED THAT THEIR DISPLAYS FAILED TO RESUME NORMAL OPERATION. THE NURSING STAFF NOTIFIED THEIR BIOMED, WHO WAS OFFSITE. IT TOOK APPROXIMATELY 45 MINUTES FOR THE BIOMED TO RESPOND. THE STAFF TOOK NO ACTION TO RESUME DISPLAY FUNCTIONALITY DURING THIS DELAY. A PATIENT SUFFERED A CARDIAC ARREST DURING THE TIME THAT THE DISPLAYS WERE BLANK, THE STAFF INDICATED THAT THE SYSTEM CONTINUED TO GENERATE ALARMS AND THEY ALSO HAD ACCESS TO PATIENT STRIPS. THE HOSPITAL BIOMED ASRIVED AT THE HOSPITAL AND RESET THE DISPLAYS, AS THE POWER INTERRUPTION HAD TRIPPED THE RESET SWITCHES. THE VIRIDIA INFORMATION CENTER IS DESIGNED TO CONTINUE TO PROVIDE AUDIO ALARMS, IN THE EVENT THAT THE DISPLAY IS BLANK. PER THE LABELING IN OUR VIRIDIA INFORMATION CENTER INSTALLATION GUIDE, SECTION 3-5, WE REQUIRE THAT THE RECORDER BE CONNECTED TO A UPS. THIS ALLOWS THE RECORDER TO CONTINUE TO FUNCTION IN THE EVENT OF A POWER LOSS. IT WAS CONFIRMED BY THE HOSPITAL MANAGER THAT THIS SYSTEM WAS CONFIGURED TO PROVIDE AUTOMATIC ALARM RECORDINGS FOR RED LEVEL ALARMS. THIS CONFIGURATION PROVIDES THE GENERATION OF A PAPER STRIP FOR PATIENTS WHO HAVE A RED LEVEL ALARM. NO FURTHER EVALUATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PART OF PHILLIPS M3150A VIRIDIA (KAYAK XA400 PC) POWER SUPPLY (3 UNITS) DRG * LA-2032-AC *
    2 PART OF PHILLIPS M3150A VIRIDIA (KAYAK XA400 PC) POWER SUPPLY (3 UNITS) DRT * LA-2032-AC *
    3 PART OF PHILLIPS M3150A VIRIDIA (KAYAK XA400 PC) POWER SUPPLY (3 UNITS) DRT * LA-2032-AC *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death