BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHILLER

    MDR report key: 17018531 · Received May 30, 2023

    Report

    Report Number
    8020045-2023-00014
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 28, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    MKJ
    UDI-DI
    19005531508129
    PMA / PMN Number
    K142803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 220505-4015 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. A PHOTO PROVIDED SHOWS ONE LEAD COMPLETELY DISCONNECTED FROM THE ELECTRODE, RING TERMINAL AND RIVET ATTACHED TO THE LEAD. IT IS UNCLEAR WHETHER THE LEAD HAS BEEN PULLED OUT FROM THE PAD BECAUSE OF A DEFECT OR BECAUSE OF AN EXCESSIVE PULL FORCE. THE INVOLVED DEVICE AND TWO ORIGINAL CLOSED POUCHES OF THE CONCERNED LOT NUMBER HAVE BEEN RECEIVED. THE INVOLVED DEVICE WAS DAMAGED AND IN A STATE NOT SUITABLE FOR ANY TESTING. THE ORIGINAL CLOSED CUSTOMER SAMPLE ELECTRODES HAVE BEEN USED FOR TESTING THE QUALITY OF THE RIVETING USING A FORCE TEST EQUIPMENT ZWICK ROELL. THEREBY 4 MEASUREMENTS HAVE BEEN CARRIED OUT. THE PULL-OUT FORCE IN THE FIRST MEASUREMENT SERIES AVERAGED 104.82N AND IN THE SECOND MEASUREMENT SERIES AVERAGED 78.09N. (THE REQUIREMENT FOR THE PULL-OUT FORCE IS 30N) IT IS UNCLEAR WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM. NO FURTHER CONCLUSION CAN BE DRAWN WE THEREFORE CLOSE THE INVESTIGATION AND THE REPORT.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT NUMBER 220505-4015 HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY FOR THE FUNCTION. ALL TESTED ELECTRODES WERE WITHIN LIMITS, NO FAILURE COULD BE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. A PHOTO PROVIDED SHOWS ONE LEAD COMPLETELY DISCONNECTED FROM THE ELECTRODE, RING TERMINAL AND RIVET ATTACHED TO THE LEAD. IT IS UNCLEAR WHETHER THE LEAD HAS BEEN PULLED OUT FROM THE PAD BECAUSE OF A DEFECT OR BECAUSE OF AN EXCESSIVE PULL FORCE. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT OUTCOME AND THE MALFUNCTION, THE INVOLVED DEVICE AND CUSTOMER SAMPLES FROM THE CONCERNED LOT NUMBER. SO FAR, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CLAIMED PROBLEM.

    Description of Event or Problem · 0

    ON MAY 04TH, 2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT A HOSPITAL PHARMACY - FARMACIA AST IN FERMO - MARCHE, ITALY. SCHILLER DEFIBRILLATION ELECTRODES MODEL SCHILLER 0-21-0040 FRED EASYPORT (OUR REF.: DF87C) AND A SCHILLER DEFIBRILLATOR DEFIGARD TOUCH 7 HAD BEEN USED. THE INITIAL REPORT STATED THAT "THE PATIENT WAS CONNECTED TO A DEFIGARD TOUCH 7 FOR MONITORING DURING TRANSPORT IN AMBULANCE CAR. THE DEFIGARD TOUCH 7 WAS PLACED ON THE HOLDING BRACKET FIXED ON THE INTERNAL WALL OF THE AMBULANCE CAR. DURING THE TRANSPORT THE DOCTOR DECIDED TO APPLY THE PADS (2.155061 LOT NUMBER 220505-4015) ON THE PATIENT BECAUSE OF A VT. AFTER THE PADS WERE PLACED, THE DOCTOR HAD TO MOVE THE PATIENT. THIS CAUSED THE PADS CABLE TO PULL. THE CABLE HAS DETACHED FROM ONE OF THE ELECTRODES. NO REPLACEMENT ELECTRODES WERE AVAILABLE. THE PATIENT WAS DEFIBRILLATED WITH A LIFEPACK 1000 AED DEFIBRILLATOR AVAILABLE IN THE AMBULANCE CAR WHICH WAS USED WITH PADS MANUFACTURER BY FIAB." NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Description of Event or Problem · 0

    ON (B)(6)2023, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT A HOSPITAL PHARMACY - (B)(6). SCHILLER DEFIBRILLATION ELECTRODES MODEL SCHILLER 0-21-0040 FRED EASYPORT (OUR REF.: (B)(4)) AND A SCHILLER DEFIBRILLATOR DEFIGARD TOUCH 7 HAD BEEN USED. THE INITIAL REPORT STATED THAT "THE PATIENT WAS CONNECTED TO A DEFIGARD TOUCH 7 FOR MONITORING DURING TRANSPORT IN AMBULANCE CAR. THE DEFIGARD TOUCH 7 WAS PLACED ON THE HOLDING BRACKET FIXED ON THE INTERNAL WALL OF THE AMBULANCE CAR. DURING THE TRANSPORT THE DOCTOR DECIDED TO APPLY THE PADS (2.155061 LOT NUMBER 220505-4015) ON THE PATIENT BECAUSE OF A VT. AFTER THE PADS WERE PLACED, THE DOCTOR HAD TO MOVE THE PATIENT. THIS CAUSED THE PADS CABLE TO PULL. THE CABLE HAS DETACHED FROM ONE OF THE ELECTRODES. NO REPLACEMENT ELECTRODES WERE AVAILABLE. THE PATIENT WAS DEFIBRILLATED WITH A LIFEPACK 1000 AED DEFIBRILLATOR AVAILABLE IN THE AMBULANCE CAR WHICH WAS USED WITH PADS MANUFACTURER BY FIAB." WE HAVE REQUESTED FURTHER INFORMATION ON THE MALFUNCTION AND THE CONCERNED SAMPLES FOR INVESTIGATION. NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649939 SCHILLER MULTIFUNCTION DEFIBRILLATION ELECTRODE MKJ LEONHARD LANG GMBH DF87C 220505-4015 19005531508129

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other