BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM

    MDR report key: 2220139 · Received August 8, 2011

    Report

    Report Number
    9610816-2011-00477
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K001664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT THE BEDSIDE CARDIAC MONITOR IS REPORTING ELEVATED PT VALUES WHICH ARE BEYOND THE ACTUAL PT VALUES. IT IS UNK WHETHER ANY "FALSE" ALARMS WERE REPORTED OR IF ANY ALARM CONDITIONS FAILED TO TRIGGER AN ALARM. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT THE BEDSIDE CARDIAC MONITOR IS REPORTING ELEVATED PT VALUES WHICH ARE BEYOND THE ACTUAL PT VALUES. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM MHX PHILIPS MEDICAL SYSTEMS M3000A

    Patients

    Seq Age Sex Outcome Treatment
    1