BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETAL MONITOR

    MDR report key: 1867773 · Received October 7, 2010

    Report

    Report Number
    9610816-2010-00577
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HFM
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS REPORTED THAT THE DEVICE FELL. IT WAS NOT REPORTED IF THE CUSTOMER DROPPED THE DEVICE OR IF THERE WAS AN INSUFFICIENT MOUNTING. THERE IS NOT SUFFICIENT INFO TO DETERMINE IF THE DEVICE WAS MOUNTED INCORRECTLY OR IF IT WAS A USER ERROR. NO ADVERSE IMPACT TO ANY PT OR USER WAS REPORTED. 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 THE DEVICE FELL.

    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