BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 16982342 · Received May 23, 2023

    Report

    Report Number
    3003832357-2023-00320
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    April 25, 2023
    Report Date
    May 22, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441058
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO STATING THE DEVICE DID NOT ALARM WHEN THE PATIENT DESATURATED. THE BENCH TECHNICIAN REPLACED THE SPO2 BOARD TO ADDRESS THE ISSUE. THE SPO2 BOARD WAS SUCCESSFULLY REPROGRAMMED AND PASSED FUNCTIONAL TESTING. THE COMPLAINT WAS CONFIRMED. NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. 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 TECHNICIAN REPLACED THE SPO2 BOARD TO ADDRESS THE ISSUE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CLINICAL INCIDENT WHERE A PATIENT APPEARED TO SIGNIFICANTLY DESATURATE DURING CARE. THE USER REVIEWED THE CASE IN EPCR AND THE DESATURATION IS OBVIOUS AND SIGNIFICANT. THE USER WANTED THE DEVICE INVESTIGATION TO ENSURE ITS OPERATION AND SAFETY. THE PATIENT WAS HEAD-INJURED, SUBSEQUENT SCANS SHOW A BRAIN BLEED AND CONTUSIONS. THE PATIENT WAS UNDER ANESTHETIC AND THE PATIENT DESATURATED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257532 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1026-R 05060472441058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other