BEUDAMED
    FDA Adverse Event Death Summary report: N

    COROMETRICS 115 FETAL MONITOR

    MDR report key: 2151672 · Received June 30, 2011

    Report

    Report Number
    9617277-2011-00005
    Event Type
    Death
    Date Received
    June 30, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    WIPRO GE HEALTHCARE PRIVATE LTD.
    Product Code
    HGM
    PMA / PMN Number
    K843385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS UNK AS THE SERIAL NUMBER PROVIDED IS INCOMPLETE.

    Description of Event or Problem · 1

    GE HEALTHCARE IS IN RECEIPT OF THE FOLLOWING INFO RECEIVED VIA A VOLUNTARY MEDWATCH REPORT (B)(4). THE REPORT STATES: FETAL DEMISE AFTER APPROX 10 HOURS OF MONITORING. PT WAS ON A COROMETRICS 256CX FETAL MONITOR THROUGH THE NIGHT. AT SOME POINT DURING THE NIGHT, NURSES WERE UNABLE TO PICK UP FETAL HEART TONES. PHYSICIAN WAS CALLED AND ARRIVED AT HOSPITAL. PHYSICIAN ATTEMPTED TO GET FETAL HEART TONES WITH THREE DIFFERENT HANDHELD DOPPLERS. DOPPLERS DID NOT PICK UP FETAL HEART TONES. PHYSICIAN ASSUMED EQUIPMENT ERROR ON ALL THREE DOPPLERS. ALL THREE DOPPLERS WERE CHECKED BY TWO SEPARATE BIOMED CONTRACTORS WITH DEFECTS FOUND IN TWO OF THE THREE. IN ADDITION, PT WAS TRANSFERRED TO A COROMETRICS 115 FETAL MONITOR AROUND 6AM ON (B)(6) 2011. THIS MONITOR STILL DID NOT PICK UP FETAL HEART TONES. BOTH COROMETRICS MONITORS HAVE BEEN CHECKED BY TWO SEPARATE BIOMED CONTRACTORS. THE 256CX CHECKED OUT FINE, BUT THE 115 DID NOT. OTHER PRODUCTS INVOLVED: HANDHELD MINI DOPPLERS - NICOLET MODEL 100. HUNTLEIGH MODEL D500. THESE TWO ITEMS WERE CHECKED BY 2 BIOMED COMPANIES AND DID NOT PASS EITHER. THE HANDHELD DOPPLERS ARE NOT GE HEALTHCARE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRICS 115 FETAL MONITOR PERINATAL MONITORING SYSTEM HGM WIPRO GE HEALTHCARE PRIVATE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death