BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO MHX

    MDR report key: 17181436 · Received June 22, 2023

    Report

    Report Number
    3003832357-2023-00397
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 24, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND A BENCH ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE UNIT TURNS ON, BUT THE TOUCHSCREEN DOESN'T WORK. DIAGNOSTICS DETERMINED THE DEVICE WOULD REQUIRE RETURN FOR REPAIR AND IT WAS RETURNED TO A PHILIPS BENCH REPAIR FACILITY. THE REPORTED COMPLAINT WAS CONFIRMED AS THE TOUCH SCREEN IS NOT WORKING. THE DISPLAY ASSEMBLY (RDT DISPLAY ASSEMBLY KIT, PART NUMBER: 453564842111) WAS REPLACED RESOLVING THE CUSTOMER¿S COMPLAINT. TESTING AND VERIFICATION WAS COMPLETED SATISFACTORILY (CALIBRATED NBP, CO2 AND TOUCH SCREEN) AND THE DEVICE WAS RETURNED TO SERVICE AT THE CUSTOMER SITE. THE REMOTE SERVICE ENGINEER RECODED THAT THE DEVICE HAD NO SCREEN PROTECTOR ON THE DEVICE. BASED ON THE INFORMATION AVAILABLE AND TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS PHYSICAL DAMAGE OF THE DISPLAY CAUSING ISSUE WITH THE TOUCH FUNCTION. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS NECESSARY AT THIS TIME. WHILE NO HARM WAS ALLEGED, RECURRENCE OF THIS FAILURE MODE DURING CLINICAL USE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THEREFORE, THIS FAILURE MODE MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION. APPROPRIATE REGULATORY REPORTING ACTIONS HAVE BEEN TAKEN. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE UNIT TURNS ON, BUT THE TOUCHSCREEN DOES NOT WORK. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134014 TEMPUS PRO MHX MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown