BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIIC IX HARDWARE

    MDR report key: 10507505 · Received September 9, 2020

    Report

    Report Number
    1218950-2020-05244
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Report Date
    September 4, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838052130
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER, AFTER THE INITIAL REPORT. THE CUSTOMER TOLD THE RCE THAT THEY HAD NO PROBLEM. THEY VERIFIED INTERNALLY AND THE PERSONNEL RESPONSIBLE FOR MEDICAL EQUIPMENT ACCEPTED THE CLOSURE OF THE CASE BY NOT FINDING A FAULT ON THE PHILIPS INFORMATION CENTER IX (PIC IX) OR INTELLIVUE MONITORS; IT WAS JUST A MISUNDERSTANDING. THERE WAS NO PRODUCT MALFUNCTION; THIS WILL BE CONSIDERED A USER ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AN ENABLED ALARM WAS NOT SOUNDING AT THE CENTRAL STATION. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ENABLED ALARM WAS NOT SOUNDING AT THE CENTRAL STATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976850 PIIC IX HARDWARE CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866424 00884838052130

    Patients

    Seq Age Sex Outcome Treatment
    1