BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERIES 50 XM FETAL/MATERNAL MONITOR

    MDR report key: 2212882 · Received August 9, 2011

    Report

    Report Number
    9610816-2011-00473
    Event Type
    Death
    Date Received
    August 9, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K900480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A FETUS WAS STILLBORN DURING MONITORING OF A PHILIPS SERIES 50 XM FETAL/MATERNAL MONITOR. THE AVAILABLE INFO STATES THAT ALTHOUGH THE FETUS WAS DEAD, THE DEVICE SHOWED TOCO VALUES AND PRINTED A TOCO DIAGRAM. ALSO A FMP HAS BEEN RECORDED. AFTER A FEW MINUTES THE PHYSICIAN DECIDED TO DO A C-SECTION BECAUSE THE RECORDED HEART RATE DID NOT CHANGE DURING A CONTRACTION. THE FETUS WAS FOUND TO BE DEAD. IT COULD BE DETERMINED THAT THE FETUS WAS STILLBORN BEFORE THE MOTHER ARRIVED AT THE HOSPITAL. A 3RD PARTY CONTRACTOR HAS BEEN ONSITE TO COLLECT ALL DATA FROM THE INCIDENT ON (B)(6) 2011, AND HAS TESTED THE DEVICE. THE INITIAL ANALYSIS OF THE PROVIDED DATA AND TESTING REVEALED THAT THERE WAS NO DEVICE MALFUNCTION DURING USE IN THIS INCIDENT. ADDITIONAL TRAINING WITH THE CUSTOMER IN REGARDS TO THE PROCEDURES FOR USE WITH THE PHILIPS SERIES 50 XM FETAL/MATERNAL MONITOR TO PREVENT INCIDENTS IN THE FUTURE HAS BEEN ARRANGED. THERE IS NO INDICATION OF ANY MALFUNCTION OF THE PHILIPS SERIES 50 XM FETAL/MATERNAL MONITOR. NOTE THAT THE USERS HAD FAILED TO VERIFY FETAL VIABILITY BEFORE COMMENCING MONITORING AS SPECIFIED IN THE DEVICE LABELING (INSTRUCTIONS FOR USE). INSTRUCTIONS FOR USE: OBSTETRICAL CARE, SERIES (B)(4), FETAL/MATERNAL MONITORS, PART NUMBER (B)(4). PAGE IV: THE MONITOR SHOULD ONLY BE USED BY, OR UNDER THE DIRECT SUPERVISION OF, A LICENSED PHYSICIAN OR OTHER HEALTH CARE PRACTITIONER WHO IS TRAINED IN THE USE OF FETAL AND MATERNAL HEART RATE MONITORS AND IN THE INTERPRETATION OF FETAL AND MATERNAL HEART RATE TRACES. PAGE 49: BE AWARE THAT FMP ANNOTATIONS ON A FETAL TRACE ALONE MAY NOT ALWAYS INDICATE THAT THE FETUS IS ALIVE. FOR EXAMPLE, FMP ANNOTATIONS IN THE ABSENCE OF FETAL LIFE MAY BE A RESULT OF: MOVEMENT OF THE DECEASED FETUS DURING OR FOLLOWING MATERNAL MOVEMENT. MOVEMENT OF THE DECEASED FETUS DURING OR FOLLOWING MANUAL PALPATION OF FETAL MOVEMENT (ESPECIALLY IF THE PRESSURE APPLIED IS TOO FORCEFUL). MOVEMENT OF THE ULTRASOUND TRANSDUCER. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO 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 A FETUS WAS STILLBORN DURING MONITORING OF A PHILIPS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 50 XM FETAL/MATERNAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M1350B

    Patients

    Seq Age Sex Outcome Treatment
    1