BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 5292798 · Received December 14, 2015

    Report

    Report Number
    9610816-2015-00302
    Event Type
    Malfunction
    Date Received
    December 14, 2015
    Report Date
    December 7, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THERE IS A STAR DEFECT IN IPM L RELATING TO STE ALARMING WHEN USING HEXAD DERIVATION: THERE IS NO STE ALARMING ON THE CHEST LEADS. A MALFUNCTION IS REPORTED TO HAVE OCCURRED WITH THE M8105A (865024) MP5. THIS ISSUE WAS DISCOVERED INTERNALLY AND DID NOT INVOLVE A PATIENT. A PHILIPS ENGINEER REPORTED THE STE ALARM IS NOT SOUNDING ON THE CHEST LEADS. THE ECG SIGNAL RESULTING IN STE VALUES FOR V1-V6 VIOLATE THE STE ALARM LIMITS. THIS COMPLAINT WAS DEEMED REPORTABLE DUE TO THE FACT THAT A "FAILURE TO ALARM" EVENT MAY CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THIS ISSUE WAS DISCOVERED INTERNALLY AND DID NOT INVOLVE A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822844 INTELLIVUE MP5 MHX MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1