BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MULTIPARAMETER PATIENT MONITOR

    MDR report key: 3252624 · Received July 15, 2013

    Report

    Report Number
    1218950-2013-03003
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    June 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K052707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RECEIVED REMOTE TECHNICAL ASSISTANCE FROM THE PHILIPS SOLUTIONS CENTER (SC) AT WHICH TIME AN SPO2 BOARD WAS ORDERED AND SHIPPED TO THE CUSTOMER FOR REPLACEMENT. NO ON SITE SUPPORT WAS REQUESTED AND NONE WAS PROVIDED. THE MONITOR REMAINS AT THE CUSTOMER SITE. PHILIPS CONCLUDED THAT THERE WAS AN SPO2 BOARD MALFUNCTION. THE REPLACEMENT SPO2 BOARD WAS SHIPPED TO THE CUSTOMER FOR THEM TO INSTALL ON THEIR OWN. THERE IS NO INDICATION THAT THE MONITOR FAILED TO ALARM IN AN "OUT-OF-LIMITS" ALARM CONDITION. PRODUCT LABELING WARNS THAT THE MOST RELIABLE METHOD OF PATIENT MONITORING REQUIRES CORRECT OPERATION OF THE MONITOR AND CLOSE OBSERVATION OF THE PATIENT. A HIGHLY ABERRANT OR QUESTIONABLE MEASUREMENT RESULT WOULD BE OBVIOUS TO CAREGIVERS DURING CLOSE OBSERVATION. THERE HAVE BEEN NO FURTHER CALLS RECEIVED FROM THE CUSTOMER FOR THIS MONITOR ISSUE. NO FURTHER INVESTIGATION/ACTION IS WARRANTED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SPO2 MEASUREMENT READING ON THE MONITOR WAS STAYING AT 100% INCORRECTLY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327683 PHILIPS MULTIPARAMETER PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 863074

    Patients

    Seq Age Sex Outcome Treatment
    1