BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 882035 · Received July 16, 2007

    Report

    Report Number
    MW5003062
    Event Type
    Malfunction
    Date Received
    July 16, 2007
    Date of Event
    July 7, 2007
    Report Date
    July 16, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    INFO CENTER ABRUPTLY CEASED OPERATING AT 11:07 PM IN 2007. AT TIME OF CESSATION, EQUIPMENT WAS PROVIDING SUPPORT FOR 7 TELEMETRY MONITORS IN HOSP CARDIOVASCULAR INTERMEDIATE CARE UNIT (CVIMC). IMMEDIATE STEPS WERE TAKEN TO PROVIDE FOR ALTERNATIVE MONITOR SUPPORT FOR AFFECTED PTS. ONE PT FOUND TO BE UNRESPONSIVE WHEN ALTERNATIVE MONITOR WAS TO BE PLACED AT 12:15 AM THE FOLLOWING DAY. SVC REP RESPONDED TO REQUEST FOR SVC AND IDENTIFIED DEFECTIVE POWER SUPPLY IN EQUIPMENT. NOT ABLE TO DETERMINE WHETHER THERE IS AN CONNECTION BETWEEN EQUIPMENT PROBLEM AND PT DEATH. NO AUTOPSY PERFORMED. PT WAS "DO NOT RESUSCITATE" STATUS. DATES OF USE: INSTALLED IN 2007. DIAGNOSIS: DEFECTIVE POWER SUPPLY IN EQUIPMENT USED TO SUPPORT MONITORS. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS PHILIPS INFORMATION CENTER MHX PHILIPS MEDICAL SYSTEMS M3155 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR PHILIPS SVC ORDER NOTES PRODUCT