BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 5000107 · Received August 13, 2015

    Report

    Report Number
    9710602-2015-00011
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT, DURING PREOPERATIVE TESTING, THE UNIT DID NOT SWITCH TO BATTERY BACKUP DURING LOSS OF AC POWER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535345 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1