BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 12234522 · Received July 27, 2021

    Report

    Report Number
    3003832357-2021-10001
    Event Type
    Death
    Date Received
    July 27, 2021
    Date of Event
    June 29, 2021
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS TO RETURN THE TEMPUS LS MANUAL FAILURE DEVICE. THE TRACKING NUMBER (B)(4) GIVEN BY CUSTOMER IS INVALID AND CUSTOMER SAID THAT SHE CAN¿T PROVIDE ANY FURTHER INFORMATION. PHILIPS ENGINEER CALLED UPS THEY HAVE NO RECORD OF A PICK-UP FROM THAT LOCATION FROM 7-28-21 TO 8-20-21. FURTHER CHECKED WITH PHILIPS WAREHOUSE IN MECHANICSBURG, PA WHERE THE DEVICE (SN: (B)(6)) WAS TO BE SENT AND DEVICE NOT RECEIVED UNTIL 11 NOV 2021.

    Additional Manufacturer Narrative · 0

    UPDATED CONTACT INFORMATION , PROBLEM CODE , EVALUATION RESULT CODE , COMPONENT CODED AND CONCLUSION CODE.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 74 YO FEMALE (DOB: (B)(6) 1946) WITH COMPLAINT OF SOB. EKG: WIDE COMPLEX JUNCTIONAL RHYTHM. DURING TRANSPORT PARAMEDIC ATTEMPTED TO PACE PATIENT AND RECEIVED THE ERROR MESSAGE - CHECK ELECTRODES. EMS NOT ABLE TO ACCESS THE PACING FEATURE ON TEMPUS LS. IT WAS REPORTED THE PATIENT OUTCOME WAS PATIENT DIED. AFTER ARRIVING BACK AT STATION PERSONNEL COMPARED THE ACTION OF THE DEFIB TO ANOTHER KNOWN GOOD TEMPUS LS AND THE TWO UNITS DID NOT WORK THE SAME. PACING FEATURE WAS NO ABLE TO BE ACCESSED ON REPORTED DEVICE. ELECTRODE PADS WERE PLACED ON EMS PERSONNEL AND THEY CONTINUED TO RECEIVE "CHECK ELECTRODES" ERROR MESSAGE. THE DEVICE HAS BEEN RECEIVED AND SENT TO MANUFACTURER FOR INVESTIGATION. IT WAS FOUND THAT THE INTERNAL CABLE CONNECTING THE ECG CONNECTOR TO THE PRINT WAS NOT IN THE CORRECT POSITION. BASED ON THE TRACES, IT MUST BE ASSUMED THAT THIS CABLE WAS MOUNTED CORRECTLY. THE CABLE HAS COME LOOSE DUE TO TWISTING OF THE ECG CONNECTOR. SUCH AN ERROR SHOULD BE NOTICED DURING THE DAILY FUNCTION TEST. ACCORDING TO LOG FILES THE DAILY FUNCTION TESTS WERE NOT DONE AS REQUIRED BY THE TO IFU.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 74 YO FEMALE (DOB: (B)(6) 1946) WITH COMPLAINT OF SOB. EKG: WIDE COMPLEX JUNCTIONAL RHYTHM. DURING TRANSPORT PARAMEDIC ATTEMPTED TO PACE PATIENT AND RECEIVED THE ERROR MESSAGE - CHECK ELECTRODES. EMS NOT ABLE TO ACCESS THE PACING FEATURE ON TEMPUS LS. IT WAS REPORTED THE PATIENT OUTCOME WAS PATIENT DIED. AFTER ARRIVING BACK AT STATION PERSONNEL COMPARED THE ACTION OF THE DEFIB TO ANOTHER KNOWN GOOD TEMPUS LS AND THE TWO UNITS DID NOT WORK THE SAME. PACING FEATURE WAS NO ABLE TO BE ACCESSED ON REPORTED DEVICE. ELECTRODE PADS WERE PLACED ON EMS PERSONNEL AND THEY CONTINUED TO RECEIVE "CHECK ELECTRODES" ERROR MESSAGE.

    Additional Manufacturer Narrative · 1

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED AND INVESTIGATION HAS PROGRESSED.

    Description of Event or Problem · 1

    THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS (B)(6) FEMALE (DOB: (B)(6)) WITH COMPLAINT OF SOB. EKG: WIDE COMPLEX JUNCTIONAL RHYTHM. DURING TRANSPORT PARAMEDIC ATTEMPTED TO PACE PATIENT AND RECEIVED THE ERROR MESSAGE - CHECK ELECTRODES. EMS NOT ABLE TO ACCESS THE PACING FEATURE ON TEMPUS LS. IT WAS REPORTED THE PATIENT OUTCOME WAS PATIENT DIED. AFTER ARRIVING BACK AT STATION PERSONNEL COMPARED THE ACTION OF THE DEFIB TO ANOTHER KNOWN GOOD TEMPUS LS AND THE TWO UNITS DID NOT WORK THE SAME. PACING FEATURE WAS NO ABLE TO BE ACCESSED ON REPORTED DEVICE. ELECTRODE PADS WERE PLACED ON EMS PERSONNEL AND THEY CONTINUED TO RECEIVE "CHECK ELECTRODES" ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130987 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death