BEUDAMED
    FDA Adverse Event Death Summary report: N

    M3150 RELEASE K.0 UPGRADE

    MDR report key: 6140865 · Received December 2, 2016

    Report

    Report Number
    1218950-2016-07574
    Event Type
    Death
    Date Received
    December 2, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 28, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION PROVIDED BY THE RESPONSE CENTER ENGINEER (RCE) THE CUSTOMER CHANGED THEIR ALLEGATION FROM FAILURE TO ALARM AT THE CENTRAL, TO THE ALARM WAS PROVIDED VISUALLY BUT NOT AUDIBLY AT THE CENTRAL STATION. THE LOGS WERE PROVIDED AND REVIEWED BY THE RCE, AS WELL AS THE QUALITY SPECIALIST. THE LOGS INDICATE THAT AT 11:03 A VENT FIB/TACHY ALARM OCCURRED WHICH WAS SUSPENDED AT 11:04, AND THEN AT 11:15 AN ASYSTOLE ALARM OCCURRED WHICH WAS SUSPENDED WITHIN SECONDS AT 11:15; THUS ALARMS WERE OCCURRING AND BEING ADDRESSED BY USERS. THE RCE STATED THAT THE FIELD SERVICE ENGINEER (FSE) AND BIOMEDICAL ENGINEER TESTED THE EQUIPMENT AND FOUND IT OPERATING PROPERLY, HOWEVER, IT HAS BEEN QUARANTINED FOR NOW. THE AVAILABLE INFORMATION INDICATES THAT THIS WAS A USER ALARM HANDLING ISSUE. NO DEVICE MALFUNCTION OCCURRED. THE PATIENT EXPIRED. THE PATIENT HAD END STAGE CANCER, AND DEATH WAS ANTICIPATED. THE CUSTOMER WAS UNWILLING TO PROVIDE ANY ADDITIONAL PATIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BED 14 DID NOT ALARM AT THE CENTRAL STATION ON (B)(6) 2016 BETWEEN 11:10-11:20 AND THE PATIENT EXPIRED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791619 M3150 RELEASE K.0 UPGRADE MONITOR, PHYSIOLOGICAL, PATIENT (W/ARRHTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS M3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death