BEUDAMED
    FDA Adverse Event Death Summary report: N

    50L ABDOMINAL INSUFFLATOR

    MDR report key: 8209824 · Received January 2, 2019

    Report

    Report Number
    1017294-2018-00187
    Event Type
    Death
    Date Received
    January 2, 2019
    Date of Event
    December 6, 2018
    Report Date
    January 2, 2019
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER NORTHGATE TECHNOLOGIES IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH (B)(4). THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, AS THIS DEVICE IS NOT MANUFACTURED BY (B)(4). A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN 5 COMPLAINTS, REGARDING 5 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME THERE HAS BEEN (B)(4) DEVICES MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE THE RATE OF FAILURE WOULD BE (B)(4). THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING DURING USE IN BARIATRIC MODE: ALWAYS MONITOR THE PATIENT'S RESPIRATORY FUNCTIONS DURING THE ENTIRE SURGERY. WHEN PUNCTURING THE THICKER ABDOMINAL WALL OF MORBIDLY OBESE PATIENTS WITH THE VERRES NEEDLE OR THE TROCAR, CAREFULLY MONITOR THE CORRECT POSITION OF THE INSTRUMENT IN THE ABDOMEN. CONSTANTLY MONITOR ALL HEART AND CARDIOVASCULAR PARAMETERS DURING SURGERY SINCE MORBIDLY OBESE PATIENTS HAVE AN INCREASED RISK OF HEART AND CARDIOVASCULAR INSUFFICIENCIES.

    Description of Event or Problem · 1

    VOLUNTARY DISTRIBUTOR REPORT. THE CUSTOMER REPORTED THAT THE GS2000 INSUFLATOR WAS INVOLVED IN A CASE WITH A DEATH. THE PROCEDURE WAS A BARIATRIC SURGERY ON (B)(6) 2018. THE CUSTOMER ASKED THE (B)(4) "REPRESETATIVE" TO COME AND INSPECT THE MACHINE TO BE SURE IT WAS FUNCTIONING AS EXPECTED. THE DEVICE WAS ONLY NAMED DUE TO THE FACT IT WAS IN THE ROOM. THE BIOMED DEPT DOES NOT FEEL THIS WAS IN ANY WAY THE CAUSE OR CONTRIBUTING TO THE DEATH. ADDITIONAL INFORMATION WAS PROVIDED TO US BY THE CUSTOMER VIA A CONFERENCE CALL AND WAS PASSED ALONG TO THE OEM, NORTHGATE TECHNOLOGIES. THEY HAVE EVALUATION AND REPORTING RESPONSIBILITY. THE DEVICE WAS SENT TO THEM ON 12/11/2018 FOR EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED FROM NORTHGATE, THE EVALUATION WAS COMPLETED 12/27/2018, THERE WAS NO FAULT FOUND WITH THE "FUNCTIONALIITY", THE SAFETY PRESSURES OR SAFETY MEASURES. BASED ON THIS INFORMATION NORTHGATE WILL NOT BE FILING TO THE FDA, PER CFR 803.50. THIS REPORT IS BEING RAISED DUE TO THE DEATH OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063 50L ABDOMINAL INSUFFLATOR INSUFLATOR HIF NORTHGATE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death