BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPU DIGITAL RECORDING SYSTEM 1080P

    MDR report key: 6430356 · Received March 23, 2017

    Report

    Report Number
    1017294-2017-00029
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    March 4, 2017
    Report Date
    April 6, 2017
    Manufacturer
    MED X CHANGE, INC
    Product Code
    LMB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS FILING, THE CPU DIGITAL RECORDING SYSTEM 1080P HAS NOT YET BEEN RETURNED FROM THE USER FACILITY FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE PRODUCT EVALUATION AND THE COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY CONTACTED THE SALES REPRESENTATIVE TO REPORT A FIRE IN THEIR OPERATING ROOM ON (B)(6) 2017, LATE IN THE EVENING WHEN THE ROOM WAS NOT IN USE. IT WAS REPORTED THAT AROUND 11:00 PM SOMEONE WALKING BY THE SURGERY ROOM NOTICED THAT THE (DRSHD-1080P) CPU DIGITAL RECORDING SYSTEM 1080P WAS ON FIRE. THE DVD WAS SMOLDERING AND BURNED THE UNIT. THE CPU DIGITAL RECORDING SYSTEM 1080P WAS CONNECTED TO A BOOM. THE FIRE DEPARTMENT WAS CALLED IN AND THE FIRE EXTINGUISHED. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO THE HOSPITAL STAFF OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212760 CPU DIGITAL RECORDING SYSTEM 1080P DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL LMB MED X CHANGE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1