BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 15777933 · Received November 11, 2022

    Report

    Report Number
    1218950-2022-00988
    Event Type
    Death
    Date Received
    November 11, 2022
    Date of Event
    November 7, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTER INSTITUTION PHONE NUMBER (B)(6). REPORTER PHONE NUMBER (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FAILURE TO ALARM FROM THE UNIT. THE DEVICE WAS IN USE AT TIME OF EVENT, A PATIENT DEATH WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FAILURE TO ALARM FROM THE UNIT. THE DEVICE WAS IN USE AT TIME OF EVENT, A PATIENT DEATH WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE SITE AFTER THE CUSTOMER REQUESTED THE EVENT BE REVIEWED. THE ENGINEER DID NOT DETECT ANY OTHER PROBLEMS DURING THE TESTING. THE ALARM AUDIT TRAIL WAS REVIEWED AND IT WAS CONFIRMED THAT AN ASYSTOLE ALARM WAS GENERATED AT THE PATIENT INFORMATION CENTER IX AS EXPECTED. AN ALARM WAS GENERATED ON (B)(6) 2022 AT 19:32. HOWEVER THE ALARM WAS NOT ACKNOWLEDGED UNTIL 19:48. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212590 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death