BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE

    MDR report key: 8503117 · Received April 11, 2019

    Report

    Report Number
    2112667-2019-00080
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    January 31, 2019
    Report Date
    August 14, 2019
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONLY INFORMATION AVAILABLE WAS CONTAINED IN FDA MEDWATCH REPORT MW5084084. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE UNIT WAS NOT EVALUATED BY GE HEALTHCARE. THE DEVICE LOGS WERE NOT MADE AVAILABLE TO GE HEALTHCARE. COMPLETE LOSS OF VENTILATION POTENTIAL CAUSES WERE REVIEWED TO DETERMINE THE MOST LIKELY ROOT CAUSES. DUE TO VERY LIMITED INFORMATION, THE ROOT CAUSE IS UNDETERMINED. THE ONLY INFORMATION AVAILABLE WAS CONTAINED IN FDA MEDWATCH REPORT MW5084084. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE UNIT WAS NOT EVALUATED BY GE HEALTHCARE. THE DEVICE LOGS WERE NOT MADE AVAILABLE TO GE HEALTHCARE. COMPLETE LOSS OF VENTILATION POTENTIAL CAUSES WERE REVIEWED TO DETERMINE THE MOST LIKELY ROOT CAUSES. DUE TO VERY LIMITED INFORMATION, THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT IDENTIFIER, AGE OR DATE OF BIRTH, WEIGHT, SERIAL NUMBER, AND MANUFACTURE DATE: NO INFORMATION AVAILABLE AS REPORT RECEIVED VIA ANONYMOUS MEDWATCH REPORT. REPORT SOURCE: REPORT RECEIVED VIA ANONYMOUS MAUDE MEDWATCH REPORT MW5084084.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT A MALE UNDERWENT A RIGHT KNEE INCISION & DRAINAGE WITH SPINAL ANESTHESIA. PROCEDURE WAS CONVERTED TO GENERAL ANESTHESIA FOR PAIN MANAGEMENT. THE PATIENT WAS INDUCED WITH PROPOFOL & SUCCINYLCHOLINE. PATIENT WAS VENTILATED WITH ANESTHESIA CIRCUIT, THEN MANUALLY BY AMBU BAG AS BAG WAS UNABLE TO FILL WITH 02 FLUSH OR HIGH FLOW 02. PATIENT INTUBATED WITH MINIMAL DE-SATURATION DURING INDUCTION. PATIENT WENT ASYSTOLE, ADVANCED CARDIAC LIFE SUPPORT WAS STARTED. PROCEDURE WAS ABORTED. PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT, INTUBATED AND WITHOUT RESPONSE, SEDATED AND PARALYZED AS PER HYPOTHERMIC PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296514 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other