BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300A

    MDR report key: 350510 · Received September 4, 2001

    Report

    Report Number
    8010042-2001-00173
    Event Type
    Malfunction
    Date Received
    September 4, 2001
    Date of Event
    July 4, 2001
    Report Date
    July 4, 2001
    Manufacturer
    SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE VENTILATOR WOULD NOT CYCLE WHILE CONNECTED TO A PT. THERE WAS A LOUD POPPING NOISE AND THE LOW EXPIRED MINUTE ALARM WAS ACTIVATED. NO OTHER ALARMS WERE NOTED BY THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39978 SERVO VENTILATOR 300A VENTILATOR CBK SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION SERVO VENTILATOR 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention