BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER CLIENT

    MDR report key: 3042061 · Received April 1, 2013

    Report

    Report Number
    1218950-2013-01000
    Event Type
    Death
    Date Received
    April 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CONTACTED PHILIPS TO HAVE LOGS REVIEWED TO CHECK FOR AN SPO2 ALARM ON (B)(6) 2013 BETWEEN THE TIMES OF 0700-0830 FOR A PT THAT ARRESTED AND EVENTUALLY EXPIRED. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE SITE TO COLLECT LOG FILES FOR REVIEW. COMMUNICATION WITH THE HOSPITAL NURSE INDICATED THAT THE SPO2 ALARM HAD BEEN TURNED OFF/DISABLED AT SOME POINT TO THE EVENT. THE LOG FILES WERE REVIEWED AND SHOW THAT NO RED LEVEL SPO2 ALARMS OCCURRED BETWEEN THE TIMES OF 0700-0830. THE LAST RED LEVEL SPO2 ALARM FOR THIS BED WAS ON (B)(6) 2013 AT 13:45. SINCE LOG FILES ONLY STORE RED ALARM EVENTS, IT CANNOT BE DETERMINED IF ANY YELLOW LEVEL SPO2 ALARMS OCCURRED. THE LOGS DO NOT PROVIDE INFO WHEN ALARM PARAMETERS ARE DISABLED OR ENABLED. NO MALFUNCTION OCCURRED. THE AVAILABLE INFO INDICATES THAT THIS IS A USER ALARM HANDLING ERROR. DEVICE LABELING ADEQUATELY DESCRIBES ALARM BEHAVIOR. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS STATING THEY WOULD LIKE TO HAVE LOGS REVIEWED TO CHECK FOR AN SPO2 ALARM FOR A PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131710 INTELLIVUE INFORMATION CENTER CLIENT MHX PHILIPS MEDICAL SYSTEMS 865094 (M3155) RP5700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death