BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM50 FETAL MONITOR

    MDR report key: 4934698 · Received July 23, 2015

    Report

    Report Number
    9610816-2015-00136
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    July 3, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K071800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "ON THE (B)(6) 2015 THE 865071 (M2705A) AVALON FM50 FETAL MONITOR S/N: (B)(4) HAD CHANGED ALARM MODE FROM ALL ALARMS TO INOP ONLY MODE AND DID NOT ALARM. THIS CAUSED DELAY TO TREATMENT SINCE STATUS WAS NOT NOTICED IMMEDIATELY. PER HEAD NURSE NO HARM FOR THE BABY OCCURRED ON POTENTIALLY DANGEROUS EVENT".

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT "ON THE (B)(6) 2015, THE 865071 (M2705A) AVALON FM50 FETAL MONITOR, S/N: (B)(4) HAD CHANGED ALARM MODE FROM ALL ALARMS TO INOP ONLY MODE AND DID NOT ALARM. THIS CAUSED DELAY TO TREATMENT SINCE STATUS WAS NOT NOTICED IMMEDIATELY. PER HEAD NURSE, NO HARM FOR THE BABY OCCURRED ON POTENTIALLY DANGEROUS EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479046 AVALON FM50 FETAL MONITOR PERINATAL MONITORING SYSTEM HGM PHILIPS MEDICAL SYSTEMS M2705A

    Patients

    Seq Age Sex Outcome Treatment
    1