BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT DATA MODULE

    MDR report key: 2822798 · Received November 2, 2012

    Report

    Report Number
    2124823-2012-00151
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THE SERIAL NUMBER AND MFR DATE OF THE PT DATA MODULE IS UNK AT THIS TIME HENCE IDENTIFICATION OF THE 510 (K) NUMBER WHICH DIRECTLY SUPPORTS THIS DEVICE IS UNCERTAIN.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THERE WAS AN ISSUE WITH THE PT DATA MODULE THAT MAY HAVE THE POTENTIAL TO AFFECT THE DEFIB SYNC FUNCTION OF THE DEVICE. THERE WAS NO REPORTED PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT DATA MODULE PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1