BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALARM

    MDR report key: 2820584 · Received October 4, 2012

    Report

    Report Number
    9610816-2012-00440
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    September 11, 2012
    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): PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THE PATIENT MONITOR FELL AND THE SLIDING SYSTEM WAS BROKEN. THERE WAS NO ALLEGATION OF A PATIENT OR USER HARM.

    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