BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 1844571 · Received September 20, 2010

    Report

    Report Number
    9610816-2010-00498
    Event Type
    Death
    Date Received
    September 20, 2010
    Report Date
    September 15, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K052795
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A PT DEATH. THEY WERE COMPLAINING THAT THE RECORDER MACHINE IS FAULTY BECAUSE, IT PRINTED OUT A PRINTER SPEED ERROR MESSAGE WHEN THERE WAS NO PROBLEM WITH THE PRINTER SPEED. BASED ON THE AVAILABLE INFORMATION, THE RECORDER PROVIDED A PRINT OUT STATING "WRONG PAPER SCALE". DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBE THE USE OF THE RECORDER AND THE PAPER. A RECENT FIELD CHANGE ORDER (FCO#(B)(4), WHICH WAS COMMUNICATED TO THE FDA ON 11MAY09) PROVIDES DETAILS FOR THE CUSTOMER TO FOLLOW TO LOAD THE PAPER AND THE PROPER SETTINGS FOR THE RECORDER. THERE IS NO INDICATION OR ALLEGATION THAT THIS PAPER SPEED ERROR MESSAGE WAS IN ANY WAY RELATED TO THE DEATH. 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 THERE WAS A PT DEATH HOWEVER, THEY ARE COMPLAINING THAT THE RECORDER MACHINE IS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FM30 FETAL MONITOR HGM PHILIPS MEDICAL SYSTEMS M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death