BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS PRO

    MDR report key: 17412797 · Received July 28, 2023

    Report

    Report Number
    3003832357-2023-00490
    Event Type
    Death
    Date Received
    July 28, 2023
    Date of Event
    April 27, 2023
    Report Date
    August 2, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441058
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MFG (RFB) UPDATED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THERE WAS A CALL FOR DYSPNEA OF A 63-YEAR-OLD MALE PATIENT WHO 3 DAYS AGO WAS DISCHARGED AFTER ANGIOPLASTY + STENT IN AD AND OM. ALONE, WITHOUT FAMILY ACCOMPANIED BY A PERSON WHO RENTS A ROOM IN THE SAME BUILDING AND WHO KNOWS NO HISTORY OR ABSOLUTELY NOTHING OF THE PATIENT BUT WHO WAIT WITH HIM, LEANING ON A CAR HOOD PARKED IN FRONT OF THE ENTRANCE DOOR OF HIS BUILDING. VERY BAD GENERAL CONDITION, REFERS NO CHEST PAIN AND ONLY NOT BEING ABLE TO BREATHE. HE IS PLACED ON A STRETCHER AND WHEN HE GETS INTO THE AMBULANCE HE ENTERS PCR. CPR MANEUVERS ARE INITIATED AND AS IN THE PREVIOUS CASE AESP IS INITIALLY OBJECTIVE, THEN ASYSTOLE AND LATER ELECTRODE CHANGES, SOMETIMES BY CONTINUOUSLY DETACHING WITH LOSS OF MONITORING BUT ALSO WITH LOSS OF MONITORING BY PATCHES CHECKING THEY WERE WELL GLUED AND WITH GOOD CONTACT. CPR IS CONTINUOUS THAT LASTS FOR +-45MINUTES (IOT/AMBU-VMI), INTRAOSSEOUS + ULTRASOUND-GUIDED CHANNELING OF VASCULAR ACCESS, BICARBONATE NA EV, ADRENALINE ..) ASYSTOLE WAS CONFIRMED BY ULTRASOUND TT, WITHOUT DILATION OF RIGHT CAVITIES OR SEVERE PERICARDIAL EFFUSION (MINIMAL TONGUE) AND AFTER 45 MINUTES IT WAS DECIDED TO SUSPEND CPR. IT BECOMES JUDICIAL. IN CONCLUSION, ALSO IN THIS CASE LOSS OF MONITORING IN PATIENT WITH CARDIORESPIRATORY PARA. IN REVIEW OF EVENTS, THERE ARE MULTIPLE OCCASIONS OF NON-MONITORING, IN ADDITION TO ASIITOLIA. THESE CASES ARE RECORDED FOR USUAL PROBLEMS OF MONITORING LOSSES , BAD CONTACT OF ELECTRODES THAT OCCUR REGULARLY SINCE THE CHANGE OF TEMPUS MONITORS, AND IN THESE 2 CASES ALREADY MUCH MORE SERIOUS DUE TO THE IMPOSSIBILITY OF PERFORMING STOP PROTOCOLS CORRECTLY, FOR NOT HAVING MONITORING DURING IT. INCIDENCIA TEMPUS 77_23 Y 78_23. UBICACIÓN: MALLORCA: PALMA DE MALLORCA. DIRECCIÓN: C/ GREMI DELS TINTORERS, NUM. 11. 07009 POLIGON INDUSTRIAL DE SON CASTELLÓ. PALMA DE MALLORCA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320675 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 63 YR Male Death