BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VM6

    MDR report key: 2933071 · Received January 22, 2013

    Report

    Report Number
    1218950-2013-00225
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PATIENT FELT ELECTRICITY (WHEN CONNECTED TO THE MONITOR). THE CUSTOMER STATED THAT LEAKAGE CURRENT CAUSED THE PATIENT TO HAVE EPILEPSY, WHICH WAS CLARIFIED AS A SEIZURE. WHICH REQUIRED MEDIATION TO BE ADMINISTERED. PHILIPS IS IN THE PROCESS OR OBTAINING ADDITIONAL INFORMATION 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 CUSTOMER REPORTED THAT THE PATIENT FELT ELECTRICITY (WHEN CONNECTED TO THE MONITOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31590 VM6 MHX PHILIPS MEDICAL SYSTEMS 863064 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1