BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1493182 · Received August 11, 2009

    Report

    Report Number
    9610816-2009-00141
    Event Type
    Malfunction
    Date Received
    August 11, 2009
    Report Date
    February 13, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL ENGINEER CALLED THE (B) (4) RESPONSE CENTER AND REPORTED THAT A PT WHOSE BREATHING WAS BEING ASSISTED VIA A VENTILATOR EXPERIENCED A DESAT EVENT, AND THERE WAS NO CHANGE IN TONE MODULATION FROM THE M1092A DISPLAY (USED WITH THE M1046A CMS COMPUTER MODULE) FOR THE EVENT. THE BIOMEDICAL ENGINEER ALSO REPORTED THAT THE NURSE HAD SET THE SPO2 PARAMETER TO TONE MODULATION. NOTE THAT THE TONE MODULATION FEATURE IS CONTROLLED VIA THE HIF BOARD. THE FIELD SERVICE ENGINEER (FSE) LEARNED THAT THE M1092A DISPLAY (WHICH CONTAINS THE HIF BOARD) HAD THE OLD VERSION HIF BOARD INSTALLED IN IT, WHICH DOES NOT HAVE TONE MODULATION CAPABILITY. THE FSE WAS CONTACTED AND ADDITIONAL INFO WAS REQUESTED ABOUT THE INCIDENT AND THE CIRCUMSTANCES UNDER WHICH THE DISPLAY CAME TO HAVE THE OLD VERSION HIF BOARD INSTALLED IN IT. THE FSE ATTEMPTED TO OBTAIN THE REQUESTED INFO. THE FSE WAS ABLE TO CONFIRM THAT THE BIOMEDICAL ENGINEERS MAINTAIN THE MONITORS. THE FSE WAS ALSO ABLE TO CONFIRM THAT THE DISPLAY INVOLVED IN THIS INCIDENT WAS THE ONLY ONE IN THE ANESTHESIA UNIT WITH THE OLD HIF BOARD INSTALLED IN IT. THE INFO REQUESTED ABOUT THE INCIDENT AND PT TREATMENT/OUTCOME WAS NOT PROVIDED BY THE CUSTOMER. BASED ON THE LIMITED INFO AVAILABLE THIS IS NOT BEING CONSIDERED A DEVICE MALFUNCTION, OR PHILIPS SERVICE RELATED MALFUNCTION. WE WILL CONSIDER THAT THE HOSPITAL BIOMEDICAL ENGINEER USED AN INCORRECT PART FOR THIS DEVICE. THE LABELING (SERVICE MANUAL) IS CLEAR AS TO WHICH PART # HIF BOARD IS TO BE UTILIZED FOR THIS MONITOR. THE TEST AND INSPECTION SPECIFIED FOR AFTER REPAIRS INSTRUCTS THE PERSON SERVICING THE DEVICE TO TEST ALL FUNCTIONALITY, SO THE LACK OF TONE MODULATION WOULD BE DETECTED IF THE TESTING WAS COMPLETED. THIS TONE MODULATION IS USED TO DETECT TRENDS IN SPO2 SATURATION, BUT IT HAS NO IMPACT ON ALARM FUNCTION, SO THERE IS MINIMAL HEALTH RISK EVENT IF, AS IN THIS INCIDENT, THIS FUNCTION IS LOST. THERE WAS NO PRODUCT OR LABELING MALFUNCTION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED. THE BIOMEDICAL ENGINEER REPLACED THE OLD VERSION HIF BOARD IN THIS DISPLAY WITH THE NEW VERSION HIF BOARD, AND THAT TONE MODULATION FUNCTIONED AS DESIGNED AND EXPECTED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WHOSE BREATHING WAS BEING ASSISTED VIA A VENTILATOR EXPERIENCED A DESAT EVENT, BUT THERE WAS NO CHANGE IN TONE MODULATION FROM THE M1092A DISPLAY (USED WITH THE (B) (4) COMPUTER MODULE) FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MHX PHILIPS MEDICAL SYSTEMS M1092A

    Patients

    Seq Age Sex Outcome Treatment
    1