BEUDAMED
    FDA Adverse Event Death Summary report: N

    XPER IM PHYSIOMONITORING SYSTEM

    MDR report key: 1821465 · Received August 26, 2010

    Report

    Report Number
    1039368-2010-00001
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 26, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS REVIEWED THE LABELLING (DOCUMENT # (B)(4) ENGLISH RELEASE 2-XPER INFO 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, CONTRA-INDICATIONS, STATES THAT "CENTRAL STATION AND PT CARE CONSOLE ARE NOT INTENDED WHERE UNATTENDED PT 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 PT." THE PHILIPS (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 (B)(4) CUSTOMER SERVICE EMPLOYEE WAS APPROACHED BY A CUSTOMER TO PROVIDE ASSISTANCE TO LOCK A PT CASE AND TO RETRIEVE FULL DISCLOSURE FILE COLLECTED ON THE XPER INFO MANAGEMENT PHYSIOMONITORING SYSTEM. SEVERAL DAYS LATER THE CUSTOMER CONTACTED THE SAME INDIVIDUAL FOR FURTHER ASSISTANCE RELATED TO THE SAME PT FILES. WHEN QUESTIONED THE CUSTOMER RELATED THAT A HOSPITAL EMPLOYEE HAD DISABLED ALL AUDIBLE ALARMS TO PERFORM OTHER DUTIES AND A PT IN THE POST CATHLAB AREA EXPIRED. THE CUSTOMER STATED THAT "THE PT DIED WHILE THE NURSE WAS CHARTING AND THEREFORE WAS NOT ABLE TO SEE THE WAVEFORM, NOR HEAR ANY ALARMS DUE TO THEM [ALARMS] BEING TURNED OFF; THIS WAS NOT AN ISSUE WITH THE PCC DEVICE. IT WAS A USER ISSUE." THE HEALTH CARE PROVIDER DID NOT ATTRIBUTE THE EVENT TO THE PHILIPS (B)(4) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER IM PHYSIOMONITORING SYSTEM XPER IM PHYSIOMONITORING 5 HOST MWI WITT BIOMEDICAL CORP, A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA INC. CENTRAL STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death