BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1873512 · Received October 14, 2010

    Report

    Report Number
    9610816-2010-00553
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT AN MP50 MONITOR BEGAN TO EMIT FUMES AND FLAMES DURING A TRAINING EXERCISE. THE FLAMES WERE OBSERVED ONLY AFTER THE BATTERY HAD BEEN REMOVED FROM THE MONITOR. NO PT WAS INVOLVED. 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 AN MP50 MONITOR BEGAN TO EMIT FUMES AND FLAMES DURING A TRAINING EXERCISE. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MHX PHILIPS MEDICAL SYSTEMS M4605A

    Patients

    Seq Age Sex Outcome Treatment
    1