BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MX700 PATIENT MONITOR

    MDR report key: 11826690 · Received May 14, 2021

    Report

    Report Number
    3007409280-2021-00003
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 26, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K182979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. TECHNICAL EVALUATION IDENTIFIED SOFTWARE J.10.50 AND THE UNIT WAS MISSING PROFILES. OPTIONS H30 A06 C06 YDS WERE UPDATED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE CORRUPT SOFTWARE. THE CUSTOMER PROFILES WERE SUCCESSFULLY RELOADED. THE UNITS FULL DISPLAY APPEARED ONCE RELOADED. THE DEVICE WAS CHECKED FOR CASE DAMAGE, THE CIRCUIT BOARDS WERE INSPECTED, AND THE UNIT WAS TESTED ON A SIMULATOR. A QC CHECKLIST WAS CONDUCTED TO INCLUDE; A DISPLAY TEST, ON/OFF POWER TEST AND A FINAL VISUAL INSPECTION ALL PASSED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    THE ORIGINAL REPORTED ISSUE STATED: THE DEVICE WOULD NOT LOAD PROFILES AND LOST DEFAULTS AND ALL PROFILES. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION OBTAINED ON (B)(6) 2021 STATED: USED AS AN ANESTHESIA MONITOR AND FAILED DURING A CASE WHILE THE PATIENT WAS ON THE TABLE. THERE WAS NO PATIENT HARM. NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722256 PHILIPS MX700 PATIENT MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FQPH2700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other