BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIC IX HARDWARE

    MDR report key: 12016765 · Received June 17, 2021

    Report

    Report Number
    1218950-2021-10647
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 17, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ONSITE SERVICE. THE INVESTIGATION FOUND CAUSES ATTRIBUTED PHILIPS AND CAUSES ATTRIBUTED TO THE CUSTOMER. ATTRIBUTED TO PHILIPS. THIS IS A PHILIPS SUPPLIED CLINICAL NETWORK (PSCN). THE FSE IDENTIFIED THAT RADIO FREQUENCY (RF) SURVEY PRE-UPGRADE WAS NOT PERFORMED PRIOR TO THE SITE NETWORK UPGRADE IN (B)(6) 2021. CHANGES IN THE CUSTOMER RF ENVIRONMENT WERE NOT IDENTIFIED (SEE ATTRIBUTED TO CUSTOMER NOTES BELOW). THE CUSTOMER WAS UPGRADED FROM A LARGE DBS PIIC REV N.01.17 TO ENTERPRISE PIICIX REV C.03.02 . INFORMATION TECHNOLOGY SERVICES (ITS) COVERAGE WAS NOT PROPERLY ASSESSED AND UPDATED. IT WAS IDENTIFIED THAT PHILIPS SHOULD USE SHIELDED CABLES FOR SYNCHRONIZATION (SYNC) AND ACCESS POINT CONTROLLERS (APCS), RE-ASSESS THE ITS COVERAGE, CHECK THE CABINET CAPACITY, ADD SYNC CABLES TO LINK ALL ITS CABINETS, REDESIGN THE ITS SYSTEM WHICH MIGHT NEED MORE APS AND SWITCHES, AND FINALLY TO CHECK AND REPAIR ALL THE FAULTY FIBER LINKS BETWEEN ACCESS SWITCHES AND DISTRIBUTION SWITCHES. ATTRIBUTED TO CUSTOMER. (1) CHANGES IN THE CUSTOMER RF ENVIRONMENT DUE TO COVID-19. POWERFUL MICROWAVES WERE INSTALLED NEXT TO THE PSCN ITS SYSTEM. (2) CUSTOMER REFURBISHING OF SOME AREAS CAUSED THE DISMANTLING OF A FEW ACCESS POINTS (APS) AND BROKEN FIBER LINKS FROM THE ITS SWITCHES TO DISTRIBUTION SWITCHES, (3) MX40 ISSUES INCLUDING BAD/OLD MX40 ELECTROCARDIOGRAM (ECG) CABLES AND THE MX40 HAD CORROSION IN THE PINS. THE FSE ADVISED THE CUSTOMER TO REPLACE THEIR OLD MX40 ECG LEADS, AND CLEAN MX40S CONTACT PINS, PURCHASE MORE APS, REFRAIN FROM USING THE MX40 IN A WARD WHERE THERE ARE NO APS OR POOR ITS COVERAGE AND FINALLY TO ARRANGE TO MOVE THE MICROWAVE DEVICES AWAY FROM THE ITS SYSTEM. THIS IS CONSIDERED A PRODUCT MALFUNCTION. THE FSE UPGRADED THE LARGE NETWORK PHILIPS INTELLIVUE INFORMATION CENTER (PIIC) TO PIICIX ENTERPRISE REV C.03.04. THIS INCLUDED ADDING NEW SWITCHES, AND UPGRADING THE ITS SYSTEM BY INSTALLING NEW FOUR APCS AND SEVEN SYNC UNITS. ADDITIONALLY, THE CUSTOMER WAS ADVISED TO REPLACE OLD MX40 ECG LEADS, CLEAN MX40 CONTACT PINS AND PROVIDE SUPPORT TO PHILIPS FOR RF/ITS COVERAGE ISSUES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SIGNAL KEEPS DROPPING OUT; INFORMED OF PATIENT HARM ON (B)(6) 2021 IN THE MORNING. THERE WAS A DELAY IN TREATMENT; THE PATIENT SUFFERED A CARDIAC ARREST, BUT IT WASN'T PICKED UP THAT QUICKLY BECAUSE THE ALARMS WERE NOT THERE DUE TO SIGNAL LOSS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SIGNAL KEEPS DROPPING OUT. THE USERS REPORTED THAT ASYSTOLE ALARMS HAPPEN ALL THE TIME DUE TO SIGNAL LOSS. THERE WAS A DELAY IN TREATMENT AND THE PATIENT SUFFERED A CARDIAC ARREST, BUT IT WASN'T PICKED UP THAT QUICKLY BECAUSE THE ALARMS ARE'NT THERE DUE TO SIGNAL LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916970 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention