BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS TELEMON C

    MDR report key: 1051188 · Received May 22, 2008

    Report

    Report Number
    1218950-2008-00270
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 4, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE TELEMON WAS NOT PROVIDING AUDIBLE ALARMS AT THE BEDSIDE. THE REMOTE TECHNICAL SUPPORT (R-TAC) DETERMINED THAT THE SPEAKER HAD FAILED AND QUOTED THE CUSTOMER PART AND PRICE INFORMATION FOR A REPLACEMENT SPEAKER ASSEMBLY. THE CUSTOMER SUBSEQUENTLY ORDERED THE REPLACEMENT SPEAKER. NORMALLY, BOTH VISIBLE ALARMS AND AUDIBLE ALARMS ARE GENERATED AT BOTH THE CENTRAL STATION AND THE TELEMON AND A SITUATION WHERE THERE WAS NO AUDIBLE ALARMS AT THE TELEMON WOULD NOT JEOPARDIZE PATIENT SAFETY AS THE CENTRAL STATION ALARM WOULD SOUND. BECAUSE THE TELEMON CAN BE USED AS AN ISOLATED MONITORING DEVICE, AND BECAUSE THE LABELING DOES NOT SPECIFY CLOSE PERSONAL OBSERVATION, RECURRENCE OF THIS FAILURE MODE COULD LEAD TO SERIOUS INJURY OR DEATH. THE REPAIRED PRODUCT/REPLACEMENT PRODUCT REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VOLUME ON THE DEVICE WAS NOT WORKING. THE CUSTOMER STATED THEY WERE NOT RECEIVING AUDIBLE TONES WHEN CONNECTING TO THE DEVICE, PATIENT WORN DEVICE. THE CUSTOMER STATED THERE WERE BATTERIES IN THE UNIT. THE PHILLIPS REMOTE TECHNICAL ASSISTANCE CENTER ADVISED THE CUSTOMER TO CHANGE THE CABLE WHICH DID NOT RESOLVE THE PROBLEM. THE CUSTOMER MENTIONED THE UNIT DID HAVE THE LOCAL ALARM ON AND WHEN THE UNIT WAS CONNECTED TO A SIMULATOR, WHEN DISCONNECTING A LEAD, THERE WAS A VISUAL ALARM BUT NOT AN AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS TELEMON C PORTABLE TELEMETRY MONITOR DSI PHILIPS MEDICAL SYSTEMS M2636C

    Patients

    Seq Age Sex Outcome Treatment
    1