BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINKS (ADULT)

    MDR report key: 6989939 · Received October 31, 2017

    Report

    Report Number
    6989939
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 13, 2015
    Report Date
    October 23, 2017
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING DEFIBRILLATION OF PATIENT, STAFF STATES THERE WAS A "POP" NOISE AND SMOKE FROM THE DEFIBRILLATOR PADS. PATIENT WAS SUCCESSFULLY DEFIBRILLATED AT 200J USING THE TZ MEDICAL DEFIB PADS (P-211-Z1) ATTACHED TO THE HIGH OUTPUT DEFIBRILLATOR IN THE OPERATING ROOM. SOOT WAS SEEN AT THE LEFT LATERAL SIDE OF THE PATIENT AND DEFIBRILLATOR PAD. PADS WERE IMMEDIATELY REMOVED FROM PATIENT AND REPLACED WITH A NEW SET. NO BURNS WERE APPARENT ON PATIENT SKIN NOTED, DEVICE AND PADS TAKEN OUT OF SERVICE FOR FURTHER EVALUATION MANUFACTURER RESPONSE FOR TZ TRANSPARENT DEFIBRILLATOR PADS (TZ MEDICAL DEFIB PADS (P-211-Z1), DEFIB PADS (PER SITE REPORTER). UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    DURING DEFIBRILLATION OF PATIENT, STAFF STATES THERE WAS A "POP" NOISE AND SMOKE FROM THE DEFIBRILLATOR PADS. PATIENT WAS SUCCESSFULLY DEFIBRILLATED AT 200J USING THE TZ MEDICAL DEFIB PADS (P-211-Z1) ATTACHED TO THE HIGH OUTPUT DEFIBRILLATOR IN THE OPERATING ROOM. SOOT WAS SEEN AT THE LEFT LATERAL SIDE OF THE PATIENT AND DEFIBRILLATOR PAD. PADS WERE IMMEDIATELY REMOVED FROM PATIENT AND REPLACED WITH A NEW SET. NO BURNS WERE APPARENT ON PATIENT SKIN NOTED, DEVICE AND PADS TAKEN OUT OF SERVICE FOR FURTHER EVALUATION MANUFACTURER RESPONSE FOR TZ TRANSPARENT DEFIBRILLATOR PADS (TZ MEDICAL DEFIB PADS (P-211-Z1), DEFIB PADS (PER SITE REPORTER). UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769029 LIFELINKS (ADULT) PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) DRO TZ MEDICAL, INC. P-211-Z1

    Patients

    Seq Age Sex Outcome Treatment
    1