BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 2363166 · Received November 30, 2011

    Report

    Report Number
    9610816-2011-00661
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Report Date
    November 16, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED RECEIVING FALSE HIGH BLOOD PRESSURE MEASUREMENTS FOR WHICH THE USER ADMINISTERED MEDICAL TREATMENT. NO PT HARM WAS REPORTED. THE INITIAL AVAILABLE INFORMATION WAS AMBIGUOUS AS TO WHAT THE PROBLEM WAS OR WHAT WAS THE INTERVENTION. A REPORTING DECISION COULD NOT BE MADE BASED ON THE INITIAL INFORMATION. FURTHER INFORMATION GATHERED FROM THE PHILIPS (B)(4). FIELD CONTACTS CONFIRMED THAT THE ISSUE WAS A FALSE HIGH READING FOR THE INVASIVE BLOOD PRESSURE MEASUREMENT (IBP) AND NOT NBP, AS ORIGINALLY REPORTED BY THE CUSTOMER. THE MONITOR WAS DISPLAYING A CONSISTENTLY HIGH IBP MEASUREMENT OF 220/150, AND BASED ON THIS ALONE, THE CLINICAL STAFF ADMINISTERED DRUGS TO REDUCE THE PT'S BLOOD PRESSURE. THE PT'S BLOOD PRESSURE WAS NOT VERIFIED BY ANY OTHER MEANS BEFORE DRUGS WERE ADMINISTERED, AND IT COULD NOT BE ESTABLISHED FOR HOW LONG THE FALSE HIGH READING OF 220/150 WAS DISPLAYED BEFORE DRUG ADMINISTRATION. AFTER A WHILE AFTER THE DRUGS WERE ADMINISTERED, DUE TO THE PRESSURE NOT DECREASING, THE BLOOD PRESSURE WAS THEN INDEPENDENTLY VERIFIED MANUALLY USING A SPHYGMOMANOMETER AND STETHOSCOPE AND IT WAS CHECKED WITH ANOTHER GOOD MODULE, AND BOTH SHOWED THAT THE REAL PRESSURE WAS TOO LOW (80/40). CONSEQUENTLY, DRUGS WERE THEN ADMINISTERED TO SUCCESSFULLY RESTORE THE BLOOD PRESSURE TO NORMAL LEVELS. NOTE THAT NO PT HARM RESULTED FROM THIS ISSUE, AND THE MEDICAL INTERVENTION (DRUG ADMINISTRATION) TRIGGERED BY THE FALSE IBP READINGS DOES NOT CONSTITUTE EMERGENT CARE, THEREFORE THIS INCIDENT IS CATEGORIZED AS A NON-ADVERSE EVENT. IN ABUNDANT CAUTION, WE WILL REPORT THIS ISSUE AS WE CANNOT RULE OUT A DEVICE MALFUNCTION, NOR CAN WE SAY FOR CERTAIN THAT THE RESULTING HIGH PRESSURE MEASUREMENT WAS DUE TO USER MISUNDERSTANDING OR ERROR. IN THIS CASE, THE CLINICAL STAFF DID NOT RECOGNIZE THAT THE CONSISTENTLY FALSE HIGH NBP READING WAS INDEED INACCURATE, THEREFORE IN THE CIRCUMSTANCES MAY NOT HAVE BEEN EASY TO DETECT. DEPENDING ON THE TYPE AND CONDITION OF THE PT, LOWERING THE BLOOD PRESSURE TOO FAR (BY ADMINISTERING DRUGS) CAN POTENTIALLY LEAD TO A DEATH OR SERIOUS INJURY. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING FALSE HIGH BLOOD PRESSURE MEASUREMENTS FOR WHICH THE USER ADMINISTERED MEDICAL TREATMENT. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER (MMS) MHX PHILIPS MEDICAL SYSTEMS M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1