BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIIC IX HARDWARE

    MDR report key: 7522929 · Received May 17, 2018

    Report

    Report Number
    1218950-2018-04327
    Event Type
    Death
    Date Received
    May 17, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 14, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PER COMMUNICATIONS WITH THE RESPONSE CENTER ENGINEER (RCE), THERE WERE NO STRIPS OR ALARM CONFIGURATION FILES AVAILABLE. THE LOGFILES PROVIDED END JUST PRIOR TO 23:00 WHICH IS WHEN THE ASYSTOLE ALARM ALLEGEDLY DID NOT OCCUR. HOWEVER, PRIOR TO 23:00 THERE WERE RED ALARMS OCCURRING FROM 22:37 TO 22:42. THE RCE ALSO STATED THAT THE NURSE AND BIOMEDICAL ENGINEER TESTED THE EQUIPMENT AND FOUND IT ALARMING TO SPECIFICATIONS. THE DEVICE REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    (B)(6). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT EXPERIENCED AN ASYSTOLE AND THERE WAS NO AUDIO OR VISUAL ALARMS AT THE CENTRAL STATION. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366471 PIIC IX HARDWARE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death