BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAPPER PH-Z RECORDER

    MDR report key: 7536744 · Received May 23, 2018

    Report

    Report Number
    7536744
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    January 3, 2018
    Report Date
    May 15, 2018
    Manufacturer
    MEDTRONIC INC
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PH MONITORING CATHETER PLACED AND FUNCTIONALITY VERIFIED PRIOR TO PATIENT LEAVING OUR FACILITY. NEW BATTERIES IN DEVICE AND DEVICE READS BATTERIES HAVE FULL CHARGE. PATIENT UNDERSTANDS HOW TO USE THE DEVISE AND DEMONSTRATES UNDERSTANDING. DEVICE WORKS APPROPRIATELY FOR APPROXIMATELY 5 HOURS AT HOME AND SHUTS OFF WITHOUT BEING TURNED OFF. THE PATIENT STATES SHE DID NOT DAMAGE, DROP OR INJURY THE DEVICE IN ANY WAY. THE PATIENT CALLED AS DIRECTED IF PROBLEMS OCCUR, BUT WE WERE UNABLE TO TROUBLESHOOT THE DEVICE. I CONTACTED MEDTRONIC THE NEXT DAY WHEN THE PATIENT RETURNED THE RECEIVER DEVICE AND WORKED WITH THE MANUFACTURER'S TECH; WE WERE UNABLE TO RETRIEVE INFORMATION FROM THE DEVICE. THE DEVICE WILL BE SENT IN FOR REPAIR. THE PATIENT WAS NOT INJURED IN ANY WAY FROM THIS EQUIPMENT FAILURE. WE HAD A LEAST (B)(4) CASES THAT THIS HAPPENED WITH. THE ISSUE WAS THAT WE WERE USING LITHIUM BATTERIES IN THE MONITOR AND IT SHOULD ONLY BE USED WITH ALKALINE. THE REP WAS THE ONE WHO DISCOVERED THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379082 DIGITRAPPER PH-Z RECORDER PH MONITOR FFT MEDTRONIC INC PH-Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT APPLICABLE.