BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL MONITOR SERIES 50 IP

    MDR report key: 2849088 · Received November 16, 2012

    Report

    Report Number
    9610816-2012-00474
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    January 31, 2004
    Report Date
    November 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    K062271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT ON (B)(6) 2004, A (B)(6) WAS BORN WITH DISABILITIES WHILE BEING MONITORED WITH A PHILIPS FETAL MONITOR. THE CUSTOMER STATED THAT THE HEART FREQUENCY SHOWN ON THE CTG WAS INCORRECTLY SHOWING INFORMATION, WHERE AN ACOUSTIC HEART RATE WAS HIGHER THAN THE RECORDED HEART RATE. AS THIS ISSUE IS UNDER INVESTIGATION AND FURTHER DETAILS HAVE BEEN REQUESTED, IT IS NOT POSSIBLE TO EVALUATE THE HEALTH RISK AT THIS TIME. DUE TO ONE NEONATE BEING BORN WITH DISABILITIES WE ARE REPORTING THIS INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2004, A (B)(6) WAS BORN WITH DISABILITIES WHILE BEING MONITORED WITH A PHILIPS FETAL MONITOR. THE CUSTOMER STATED THAT THE HEART FREQUENCY SHOWN ON THE CTG WAS INCORRECTLY SHOWING INFORMATION, WHERE AN ACOUSTIC HEART RATE WAS HIGHER THAN THE RECORDED HEART RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR SERIES 50 IP HFM PHILIPS MEDICAL SYSTEMS M1353A

    Patients

    Seq Age Sex Outcome Treatment
    1