BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 14187730 · Received April 22, 2022

    Report

    Report Number
    1218950-2022-00358
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 28, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHILIPS REMOTE CLINICAL APPLICATION SUPPORT SPECIALIST (RCASS) SPOKE WITH THE BIOMED. THE RCASS EXPLAINED TO THE BIOMED THAT THEY WOULD NEED TO HAVE THE CUSTOMER LOOK AT THE BEAT LABELING TO SEE WHAT THE PHILIPS INTELLIVUE INFORMATION CENTER IX (PIIC IX) IS LABELING THE BEATS AND IF THERE WERE ANY BREAKS OR WHAT THE QRS LOOKED LIKE. THE RCASS INFORMED THE BIOMED THAT THEY WOULD ALSO NEED THE STRIPS TO VIEW IN ORDER TO ASSIST. THE RCASS SENT THE BIOMED RELATED DOCUMENTS FROM THE STAR APP NOTE EXPLAINING BEAT LABELING. THE BIOMED WAS NOT ONSITE AND WOULD CONTACT THE UNIT TO EXPLAIN THE SAME OPTIONS THE RCASS PROVIDED TO THE BIOMED AS WELL AS MATERIALS TO PASS TO THE STAFF IN ASSISTING THEM IN ANALYZING THE BEATS AND RHYTHMS. THE BIOMED DID NOT CALL BACK AND ATTEMPTS TO REACH BACK OUT TO THE BIOMED WERE UNSUCCESSFUL AS THE BIOMED DID NOT RESPOND. THE CAUSE WAS NOT DETERMINED, PROVIDED, OR CONFIRMED AS LIMITED INFORMATION AND COMMUNICATION WAS PROVIDED BY THE CUSTOMER. THE RCASS PROVIDED THE BIOMED WITH INFORMATION ON BEAT LABELING AND THE BIOMED WOULD PASS ALONG THE INFORMATION AS WELL AS ADDITIONAL MATERIAL TO HELP THE CUSTOMER IN ANALYZING THE BEATS AND RHYTHMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HEART RATE ALARMS WERE NOT ALARMING OR WERE OUT OF SYNC. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741490 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS NORTH AMERICA LLC 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown