BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX C ST RP5810 PC

    MDR report key: 16205609 · Received January 19, 2023

    Report

    Report Number
    1218950-2023-00036
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 22, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT REPORTING VITALS DURING A CODE RESULTING IN A PATIENT DEATH.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PIC IX HARDWARE INDICATING THAT THE MONITOR WAS NOT REPORTING VITALS DURING A CODE, AND THE PATIENT HAD TO BE RESUSCITATED AND EVENTUALLY DIED. THE CAUSE OF DEATH IS UNKNOWN. THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT DIE BECAUSE OF THE ALLEGED EQUIPMENT FAILURE. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THAT THE PIIC WAS ALARMING CORRECTLY AND WAS CONNECTED TO THE NETWORK AND SYSTEM.BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN, AS THERE IS LIMITED INFORMATION AVAILABLE. A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO REQUEST ADDITIONAL INFORMATION FOR FULL ANALYSIS REGARDING THE EVENT, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368821 PIC IX C ST RP5810 PC PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death