BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 15655406 · Received October 21, 2022

    Report

    Report Number
    1218950-2022-00928
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 27, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SPO2 ALARM IS MUTED. A PHILIPS REMOTE CLINICAL SPECIALIST (RCS) SPOKE WITH CUSTOMER AND FOUND THAT THE PULSE LABEL IN THE SECTOR NEEDED TO BE CHANGED TO PULSE T FOR TELE BOX AND NOT JUST PULSE WHICH WOULD BE ASSOCIATED WITH THE BEDSIDE MONITOR. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SPO2 ALARM IS MUTED AND ALSO THAT THE STAFF WAS NOT ABLE TO SEE THE ELECTROCARDIOGRAM/ARRHYTHMIA (ECG/ARRH) ALARMS OF THE PATIENT ON THE TELEMETRY PIC. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. THE CUSTOMER CONTACTED THE REMOTE PHILIPS CLINICAL SUPPORT STATING THE ALARMS ARE TURNED OFF AT THE PATIENT INFORMATION CENTER IX (PIC IX) SYSTEM AND NEEDED TO TROUBLESHOOT THE ISSUE. THE REMOTE CLINICAL SPECIALIST (RCS) FOUND THAT THE PULSE LABEL IN THE AFFECTED SECTOR WAS INCORRECTLY SET FOR "PULSE" WHICH IS SYSTEM PULSE. WHEN CONFIGURED FOR "PULSE", THE ALARM IS TURNED OFF UNTIL THE PULSE IS NEEDED. THIS MEANS THAT THE "PULSE" ALARM ONLY ACTIVATES IF ECG GOES OUT AND SYSTEM PULSE TAKES OVER FOR HEART RATE (HR). PULSE WAS NOT NEEDED IN THIS CASE SINCE THE CUSTOMER WAS GETTING THE HR FROM THE ECG. UNDER THESE CONDITIONS, IT APPEARED TO THE CUSTOMER THAT THE PULSE WAS MUTED. THE RCS FURTHER DETERMINED THAT THE CUSTOMER NEEDED TO USE THE LABEL OF "PULSET" SINCE THE TELEMETRY BOX WAS IN USE. THE RCS ASSISTED IN CHANGING THE AFFECTED SECTOR TO "PULSET" TO RESOLVE THE ISSUE. THE INVESTIGATION FOUND NO PRODUCT MALFUNCTION BUT A MISUNDERSTANDING OF THE SYSTEM ICONS. THIS IS CONSIDERED A USER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462118 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown