BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ LT

    MDR report key: 3023394 · Received March 1, 2013

    Report

    Report Number
    3023750-2013-00034
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    PMA / PMN Number
    K033378
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON SITE ANALYSIS BY THE HOSPITAL'S BIOMEDICAL ENGINEERING WITH THE ASSISTANCE TO WELCH ALLYN TECHNICAL SUPPORT FOUND ALL PROPAQ LT MONITORS WERE FUNCTIONING AS INTENDED. BIOMEDS ARE DOING DAILY EQUIPMENT CHECKS TO ENSURE THAT EVERYTHING IS WORKING AS EXPECTED. IN ADDITION, WELCH ALLYN PROVIDED REPLACEMENT LARGE DISPLAY AND CHARGING CRADLES FOR THE PROPAQ LT. THE MONITOR WILL NOT BE RETURNED FOR EVALUATION. WE ARE FILING IN AN ABUNDANCE OF CAUTION. METHOD: THE DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. OTHER (BMET COULD NOT CONFIRM THE FAILURE). CONCLUSIONS: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THERE HAVE BEEN INSTANCES WHERE THEIR WELCH ALLYN PROPAQ LT MONITORS AND ITS LARGE 17 INCH DISPLAYS TURNED OFF SIMULTANEOUSLY. HOWEVER, THE CUSTOMER DID NOT HAVE SPECIFIC DATES, TIMES, OR FREQUENCY OF OCCURRENCE. WHILE ONE SERIAL NUMBER WAS PROVIDED (KV001288), THE CUSTOMER COULD NOT IDENTIFY WHETHER THAT UNIT OR OTHER UNITS ACTUALLY EXHIBITED THE BEHAVIOR AND NO UNITS WERE RETURNED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90493 PROPAQ LT DRT WELCH ALLYN PROTOCOL, INC. PROPAQ LT

    Patients

    Seq Age Sex Outcome Treatment
    1