BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2243801 · Received July 29, 2011

    Report

    Report Number
    9610816-2011-00434
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 1, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THIS INTELLIVUE MMS HAD A BROKEN CASE DUE TO A DROP. NO PT ALARM WAS REPORTED. AS OF (B)(4) 2011 NO ADDITIONAL INFO WAS PROVIDED AS TO HOW THE DEVICE HAS BROKEN THE CASE (IF THIS WAS AN UNEXPECTED FALL OR AN ACCIDENTAL USER RELATED DROP), THEREFORE, PHILIPS WILL REPORT THIS INCIDENT IN ABUNDANT CAUTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT 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 THIS INTELLIVUE MMS HAD A BROKEN CASE DUE TO A DROP. NO PT ALARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1