BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSEAL IFS, 110V

    MDR report key: 17606032 · Received August 23, 2023

    Report

    Report Number
    1320894-2023-00163
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 13, 2023
    Manufacturer
    W.O.M. WORLD OF MEDICINE GMBH
    Product Code
    HIF
    UDI-DI
    10851885004587
    PMA / PMN Number
    K190303
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT OF ¿PNEUMOTHORAX¿ WAS NOT CONFIRMED DURING THE EVALUATION PROCESS. PERFORMED ANNUAL INSPECTION, CALIBRATION, SAFETY TESTS AND PLACED UNIT ON A 12-HOUR BURN-IN TEST. THE UNIT COMPLETED AND PASSED THE 12-HOUR BURN-IN TEST. UPGRADED THE SOFTWARE TO 2.2.1.0. THE UNIT WAS TESTED PER IP-800-031. THE UNIT FUNCTIONS AS PER THE SPECIFICATION. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: READ THE INSTRUCTIONS FOR USE CAREFULLY AND BECOME FAMILIAR WITH THE OPERATION AND FUNCTION OF THE DEVICE AND THE ACCESSORIES BEFORE USE DURING SURGICAL PROCEDURES. NON-OBSERVANCE OF THE INSTRUCTIONS LISTED IN THIS MANUAL CAN LEAD TO LIFE-THREATENING INJURIES OF THE PATIENT, TO SEVERE INJURIES OF THE SURGICAL TEAM, NURSING STAFF OR SERVICE PERSONNEL, OR TO DAMAGE OR MALFUNCTION OF DEVICE AND/OR ACCESSORIES. THE DEFAULT GAS SETTINGS ARE SELECTED AT THE FACTORY AND SHOULD BE CHANGED AS NECESSARY BY THE USER. IF A GAS SUPPLY OF GREATER THAN 15 BARS/218 PSI IS SUPPLIED TO THE DEVICE, REGARDLESS IF THE DEFAULT SETTING IS SET TO BOTTLE GAS OR HOUSE GAS, THE DEVICE WILL AUTOMATICALLY DEFAULT TO BOTTLE GAS MODE. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 110V WAS BEING USED ON (B)(6) 2023 AND ¿DURING SURGERY GAS WAS LOW ON 1 TANK AFTER SWITCHED TANKS NO GAS CAME OUT. PER TRANSPLANT COORDINATOR THEY DO NOT THINK THE GAS WAS TURNED ON BY STAFF. DOCTOR SAID SURGERY CAUSED PNEUMOTHORAX, PATIENT OK PER DOCTOR.¿. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE WITH NO REPORT OF MALFUNCTION BEING USED DURING A PROCEDURE WHERE THE PATIENT EXPERIENCED PNEUMOTHORAX.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 110V WAS BEING USED ON (B)(6) 23 AND ¿DURING SURGERY GAS WAS LOW ON 1 TANK AFTER SWITCHED TANKS NO GAS CAME OUT. PER TRANSPLANT COORDINATOR THEY DO NOT THINK THE GAS WAS TURNED ON BY STAFF. DOCTOR SAID SURGERY CAUSED PNEUMOTHORAX, PATIENT OK PER DOCTOR.¿. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE WITH NO REPORT OF MALFUNCTION BEING USED DURING A PROCEDURE WHERE THE PATIENT EXPERIENCED PNEUMOTHORAX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137757 AIRSEAL IFS, 110V INSUFFLATOR, LAPAROSCOPIC HIF W.O.M. WORLD OF MEDICINE GMBH 10851885004587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other