BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 3900388 · Received May 6, 2014

    Report

    Report Number
    2112667-2014-00080
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(4) LAW AND (B)(4) DATA PROTECTION ACT 1998, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTEDLY NOTED THAT THE UNIT PROVIDED VISUAL ALARMS, HOWEVER, AUDIBLE ALARMS WERE NOT FUNCTIONAL. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271484 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1