BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER

    MDR report key: 4533169 · Received February 20, 2015

    Report

    Report Number
    1218950-2015-01038
    Event Type
    Death
    Date Received
    February 20, 2015
    Report Date
    February 16, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PATIENT DEATH WAS REPORTED BY THE CUSTOMER. A REVIEW OF THE LOGS PROVIDED FOR BED LIT106 ON (B)(6) 2015 AROUND 10:45AM FOUND ASYSTOLE AND APNEA ALARMS HAD OCCURRED WHICH WERE EITHER SILENCED AND/OR SUSPENDED BY THE USERS. (SEE BELOW LOG EXCERPT). PER COMMUNICATIONS WITH KM, (B)(4), THERE WAS NO TESTING PERFORMED ON THE DEVICE. 10:39:57, (B)(6) 2015, LIT106 ALARM *** APNEE, 10:40:20, (B)(6) 2015, LIT106 ALARM ***BRADY 39 < 40, 10:42:18, (B)(6) 2015, LIT106 ALARM *** ASYSTOLIE, 10:43:56, (B)(6) 2015, LIT106 RED ALARM SOUND -BED, 10:44:00, (B)(6) 2015, LIT106 RED ALARM SOUND -BED, 10:44:23, (B)(6) 2015, SILENCED LIT106 *** ASYSTOLIE. 10:54:07, (B)(6) 2015, LIT106 ALARM *** ASYSTOLIE ; 10:54:07, (B)(6) 2015, LIT106 ALARM *** APNEE; 10:54:09, (B)(6) 2015, LIT106, LBN 29, ALARMS SUSPENDED; 10:57:14, (B)(6) 2015, LIT106 ALARM *** ASYSTOLIE; 10:57:14, (B)(6) 2015, LIT106 ALARM *** APNEE; 11:02:18, (B)(6) 2015, LIT106, LBN 29, ALARMS SUSPENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS BEING MONITORED BY A MONITOR THAT WAS CONNECTED TO THE CENTRAL STATION. THE CUSTOMER REPORTED THAT AN ECG ALARM DID NOT SOUND AND A PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123940 INTELLIVUE INFORMATION CENTER CENTRAL STATION MHX PHILIPS MEDICAL SYSTEMS M3150 RP5700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death