BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL MONITOR

    MDR report key: 2879057 · Received December 10, 2012

    Report

    Report Number
    9610816-2012-00496
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    December 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED BPM WAS UNDER 80 AND THE ALARMS WERE NOT SOUNDING. THE BABY WAS REVIVED AFTER BIRTH AND THE BABY IS CURRENTLY STABLE AT THE NEONATAL ICU. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO CONCERNING THIS EVENT 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 BPM WAS UNDER 80 AND THE ALARMS WERE NOT SOUNDING. THE BABY WAS REVIVED AFTER BIRTH AND THE BABY IS CURRENTLY STABLE AT THE NEONATAL ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL MONITOR HFM PHILIPS MEDICAL SYSTEMS M1351A

    Patients

    Seq Age Sex Outcome Treatment
    1