BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLAR 8000I

    MDR report key: 1172346 · Received September 23, 2008

    Report

    Report Number
    2124823-2008-00074
    Event Type
    Death
    Date Received
    September 23, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 23, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K071073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATED THE LOGS AND NOTED THAT ON THE EVENT DATE, THERE WERE SPO2 ALARMS REPORTED AROUND THE TIME THE CUSTOMER NOTICED THE SPO2 AT LOW SAT AND THE ALARM LEVEL WAS AT ADVISORY. FROM THE LOG, IT IS CONFIRMED THAT THE SPO2 ALARM LEVEL AT ~13:50 WAS ADVISORY. HOWEVER, ACCORDING TO THE LOG, THE SPO2 ALARM LEVEL WAS ALREADY AT ADVISORY AT A VERY EARLY TIME IN 2008. THE FIRST SPO2 ALARM WAS REPORTED AT 04:39:11.953 ON THE SAME DAY, INDICATED THE ALARM LEVEL WAS ALREADY SET AT ADVISORY. INVESTIGATION INTO THE CIC LOGS FROM ONE DAY PRIOR, IT SHOWED THAT THE SPO2 ALARM LEVEL WAS ALSO AT ADVISORY FOR THE ENTIRE TIME ON THE SAME DAY. BASED ON THIS INFO, IT WAS CONCLUDED THAT THE SPO2 ALARM LEVEL WAS SET TO ADVISORY. THE FOLLOWING DAY, AROUND THE TIME THE CUSTOMER REPORTED SPO2 ALARMS ALARM LEVEL ISSUE, THERE WERE ALSO OTHER ALARMS REPORTED SUCH AS BRADY, IRREGULAR. ETC. NO ACTIONS WERE TAKEN AS THE SOLAR MONITOR PERFORMED AS DESIGNED WHEN ALARM LIMITS WERE MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BEING MONITORED VIA A SOLAR MONITOR IN ICU BED 123. THE PATIENT ATE LUNCH, AND, AFTERWARDS, PUT HIS O2 MASK BACK ON. THE PT REPORTED TO HIS NURSE THAT HE WAS GOING TO TAKE A NAP, AND ROLLED ON HIS SIDE TO SLEEP. THE NURSE PULLED THE CURTAIN TO GIVE THE PT SOME PRIVACY. APPROXIMATELY 45-50 MINUTES LATER, THE NURSE CHECKED ON THE PT AND FOUND HIM UNRESPONSIVE AND DESATURATED TO 48%. A CODE WAS CALLED. THE PT WAS RESUSCITATED AND PLACED ON A VENTILATOR. THE PT WAS SUBSEQUENTLY CLASSIFIED AS BRAIN DEAD. THE PT'S FAMILY DECLARED HIM TO BE DNR. THE PT WAS REMOVED FROM LIFE SUPPORT IN 2008, AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 8000I PATIENT MONITOR MHX GE HEALTHCARE 2019989-002

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death