BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER IM PHYSIOMONITORING SYSTEM

    MDR report key: 2850953 · Received November 19, 2012

    Report

    Report Number
    1039368-2012-00002
    Event Type
    Death
    Date Received
    November 19, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 19, 2012
    Manufacturer
    WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC.
    Product Code
    MWI
    PMA / PMN Number
    K063840
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS REVIEWED THE LABELING (DOCUMENT # (B)(4) ENGLISH RELEASE 2- XPER INFORMATION MANAGEMENT (XIMS) INSTRUCTIONS FOR USE) TO ENSURE THAT IT WAS ADEQUATE. SECTION 1.1, INTENDED USE, STATES THAT "OPERATOR-ADJUSTABLE ALARMS (BOTH VISUAL AND AUDIBLE), ALERT THE OPERATOR TO ANOMALOUS OCCURRENCES AND FACILITATE TIMELY RESPONSES." SECTION 1.2, CONTRAINDICATIONS, STATES THAT "CENTRAL STATION AND PATIENT CARE CONSOLE ARE NOT INTENDED WHERE UNATTENDED PATIENT MONITORING IS DESIRED..." SECTION 2.4.37, ALARM ACTIVATION RESPONSIBILITY, STATES "...PROVIDES VISUAL AND AUDIBLE ALARMS. IT IS NOT DESIGNED FOR UNATTENDED USE. ALARMS MAY BE ACTIVATED AND DEACTIVATED AT THE OPERATOR'S DISCRETION. IT IS THE OPERATOR'S RESPONSIBILITY TO CONFIGURE AND ACTIVATE THE ALARMS FOR EACH PATIENT." THE PHILIP'S (B)(4) DEVICE PERFORMED AS INTENDED. PLEASE NOTE THAT THERE WAS NO ALLEGATION AND NO COMPLAINT FROM THE ACCOUNT REGARDING THE DEVICE BEING ASSOCIATED TO THIS ISSUE.

    Description of Event or Problem · 1

    A PHILIPS HEALTHCARE MELBOURNE, (B)(6) CUSTOMER SERVICE EMPLOYEE WAS APPROACHED BY A CUSTOMER TO PROVIDE ASSISTANCE TO RETRIEVE FULL DISCLOSURE FILE COLLECTED ON THE XPER INFORMATION MANAGEMENT PHYSIO MONITORING SYSTEM. A DAY LATER, THE CUSTOMER CONTACTED THE SAME CUSTOMER SERVICE INDIVIDUAL FOR FURTHER ASSISTANCE RELATED TO THE SAME PATIENT FILES. WHEN QUESTIONED, THE CUSTOMER REVEALED A PATIENT DEATH OCCURRED WHILE THE PATIENT WAS BEING MONITORED. THE CUSTOMER FURTHER RELATED THAT THE HOSPITAL EMPLOYEE HAD DISABLED ALL AUDIBLE ALARMS IN ADDITION TO CHANGING THE TIME INTERVALS FOR VITALS BEING MONITORED TO 30 MINUTES INSTEAD OF 5 MINUTE INTERVALS AS INTENDED. THE CUSTOMER SERVICE EMPLOYEE FURTHER STATED "CUSTOMER REQUESTED NO CALL BE PUT IN OUR DATABASE AS HE FEELS THIS WAS USER CHANGING THE TIME INTERVALS ON THE MACROS PRIOR TO THIS PATIENT AND THE STAFF ACCIDENTALLY SET THE MACROS FOR A CONSTANT 30 MINUTE INTERVAL FOR VITALS." THE HEALTH CARE PROVIDER DID NOT ATTRIBUTE THE EVENT TO THE PHILIP'S (B)(4) DEVICE. THE CUSTOMER ALSO INFORMED THE SAME CUSTOMER SERVICE EMPLOYEE THAT THE SYSTEM IS OUT OF USE BY THE HOSPITAL AND IS NOT ABLE TO BE RETURNED TO PHILIPS HEALTHCARE (B)(4) FOR FURTHER INVESTIGATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER IM PHYSIOMONITORING SYSTEM XPER IM PATIENT CARE CONSOLE MWI WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC. 4522 300 34931

    Patients

    Seq Age Sex Outcome Treatment
    1 Death