BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP5

    MDR report key: 2062981 · Received March 16, 2011

    Report

    Report Number
    9610816-2011-00147
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A DEVICE HAD FALLEN. NO PT HARM WAS REPORTED. THE INITIAL REPORT INDICATED THAT THE CALLER DID NOT KNOW THE CIRCUMSTANCE OF THE FALL. THERE IS NO INDICATION OF ANY MOUNTING FAILURE. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 CUSTOMER REPORTED THAT A DEVICE HAD FALLEN. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1