BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS AVALON

    MDR report key: 6756474 · Received August 1, 2017

    Report

    Report Number
    6756474
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    June 17, 2017
    Report Date
    July 12, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE NOTICED BLOOD PRESSURE (BP) 185/154, HEART RATE (HR) 139 ON BEDSIDE FETAL MONITOR. READING DID NOT MATCH THE PATIENT CLINICALLY. RECHECK WITH DIFFERENT CUFF ON SAME MACHINE. BP 203/189, HR 75. MANUAL BP RECHECKED - 155/100. IT WAS UNCLEAR AT THIS TIME IF MONITOR OR CUFFS ARE MALFUNCTIONING. DECISION WAS MADE TO REMOVE THIS MONITOR FROM THE PATIENT'S ROOM AND REPLACE IT WITH A DIFFERENT MONITOR. A WORK ORDER WAS PLACED FOR BIOMED TO CHECK THE DEVICE. THE BIOMED MANAGER AND (B)(6) MANAGER HAVE BEEN TRACKING AND TRENDING THIS ISSUE SINCE (B)(6). THE MONITOR WAS IMMEDIATELY TESTED, CALIBRATED, AND WAS CLEARED FOR USE. WE WILL CONTINUE TO FOLLOW THIS PROCESS FOR FUTURE ERRONEOUS BP READINGS. THERE WAS NO HARM TO PATIENT. THE DEVICE WAS RETURNED FOR USE IN CLINICAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537094 PHILIPS AVALON SYSTEM, MONITORING, PERINATAL HGM PHILIPS MEDICAL SYSTEMS FM30/M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR