BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM

    MDR report key: 3962906 · Received May 29, 2014

    Report

    Report Number
    3962906
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 20, 2014
    Report Date
    May 29, 2014
    Manufacturer
    WITT BIOMEDICAL CORPORATION
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    BOTH CENTRAL PATIENT MONITORS WENT COMPLETELY BLANK AT 0225. CHARGE NURSE TRIED TO RECTIFY SITUATION WITH REBOOT, WITHOUT SUCCESS. BIOMED IDENTIFIED THAT THE PROBLEM WAS THE UPS BATTERY BACK UP WAS DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317511 XPER INFORMATION MANAGEMENT PHYSIOMONITORING 5 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE MWI WITT BIOMEDICAL CORPORATION HOST PC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NOT APPLICABLE.