BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 15025494 · Received July 15, 2022

    Report

    Report Number
    3003832357-2022-00017
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    May 11, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER WAS ASKED TO PROVIDE THE RESCUE FILES BY THE SCHILLER MANUFACTURER. INVESTIGATION WAS NOT ABLE TO PROCEED AS REQUESTED FILE WAS UNAVAILABLE UNTIL (2022-06-22) . THE REQUESTED FILES HAVE NOT BEEN PROVIDED TO SCHILLER AG. THEREFORE NO INVESTIGATION COULD BE PERFORMED. HOWEVER, BASED ON THE PROVIDED INFORMATION BY THE CUSTOMER, A USE ERROR CAN MOST LIKELY BE RULED OUT, AS THE CUSTOMER SWAPPED OUT THE DEFI PADS IMMEDIATELY WHEN THEY REALIZED THIS ISSUE. FURTHERMORE, THE CUSTOMER ALSO STATED THAT THIS ISSUE WAS REPRODUCIBLE AFTER THE INTERVENTION, AND THEY RULED OUT THAT THE PADS WERE FAULTY BY APPLYING THE SAME PADS TO A SECOND DEVICE ON WHICH THEY WERE ABLE TO RECORD AN ECG SIGNAL. THE INVESTIGATIONS INVOLVED A "GOOD FAITH EFFORT" TO OBTAIN INFORMATION AND THE DEVICE FOR THE INVESTIGATION. DESPITE ALL THE EFFORTS, SCHILLER WAS NOT ABLE TO OBTAIN THE REQUESTED INFORMATION AND DEVICE. THEREFORE, NO INVESTIGATION COULD BE DONE.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER 'DOES NOT RECOGNIZE DEFIB PADS WHEN ATTACHED. CHECK ELECTRODES MESSAGE'. THE PATIENT PADS WERE BEING USED ON A CARDIAC ARREST PATIENT. THESE PADS HAD BEEN OPENED PRIOR TO THE CALL AND HAD BEEN KEPT IN THEIR OPENED PACKAGE. THEY HAD NOT BEEN USED OR REMOVED FROM THE PACKAGE; THE PACKAGE WAS JUST OPENED FOR EASE OF ACCESS. WHEN THESE PADS WERE PLACED ON THE PATIENT THE TEMPUS LS DID NOT RECOGNIZE THAT THE PADS HAD BEEN CONNECTED TO THE MONITOR. MY CREW THOUGHT THAT IT WAS A PROBLEM WITH THE PAD AND RETRIEVED AN UNOPENED SET FROM THE MEDIC UNIT. THESE PADS ALSO WERE NOT RECOGNIZED BY THE MONITOR. WHEN I RETURNED TO THE OFFICE ON THE FOLLOWING DAY THE SHIFT SUPERVISOR AND MYSELF OPENED A SET OF UNISSUED PADS FROM OUR SUPPLY ROOM AND ATTEMPTED TO SEE IF THESE WOULD CONNECT AND BE RECOGNIZED BY THE MONITOR. THEY WERE NOT RECOGNIZED BY THE LS THAT WE SENT IN BUT WERE RECOGNIZED BY A SECOND LS THAT WE USED TO HELP IDENTIFY THE PROBLEM. THE PADS WERE PLACED ON ME AND WERE RECOGNIZED ON THE SECOND LS BUT NOT THE ¿BROKEN¿ LS. NOTHING WAS ATTACHED TO THE PADS THEMSELVES OTHER THAN THEIR NORMAL PACKAGING. THEY WERE PLUGGED INTO THE LS. THE CURRENT SETS I HAVE ARE PN 01-3020. FROM THE MANUFACTURER INITIAL EVALUATION- BASED ON THE PROVIDED INFORMATION BY THE CUSTOMER, A USE ERROR CAN MOST LIKELY BE RULED OUT, AS THE CUSTOMER SWAPPED OUT THE DEFIB PADS IMMEDIATELY WHEN THEY REALIZED THIS ISSUE. FURTHERMORE, THE CUSTOMER ALSO STATED THAT THIS ISSUE WAS REPRODUCIBLE AFTER THE INTERVENTION AND THEY RULED OUT THAT THE PADS WERE FAULTY BY APPLYING THE SAME PADS TO A SECOND DEVICE ON WHICH THEY WERE ABLE TO RECORD AN ECG SIGNAL.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER AND SCHILLER INVESTIGATION TEAM AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE DOES NOT RECOGNIZE DEFIB PADS WHEN ATTACHED AND GETTING A CHECK ELECTRODES MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452455 TEMPUS LS - MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other