BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 FM

    MDR report key: 2201321 · Received August 3, 2011

    Report

    Report Number
    9610105-2011-00021
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 3, 2011
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    MHX
    PMA / PMN Number
    K043276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE S/5 DEVICE HAS BEEN REPAIRED AND RETURNED TO SERVICE. THE BURNED MODULE IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN S/5 PM MULTI I/O ADAPTOR MODULE APPEARED TO BE BURNED FROM THE INSIDE OUT WITH MELTING OF THE EXTERNAL ENCLOSURE. IT WAS NOT REPORTED IF THE UNIT WAS IN USE AT THE TIME. THERE WAS NO REPORT OF PT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 FM PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1