BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA

    MDR report key: 876158 · Received July 2, 2007

    Report

    Report Number
    MW5002919
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Report Date
    July 2, 2007
    Manufacturer
    GENERAL ELECTRIC COMPANY/ DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AESTIVA MACHINES INTERMITTENTLY PRODUCED PEEP IN PATIENT -BAG- MODE. WE HAVE REPORTED OBSERVING PEEP AS HIGH AS 15-20 CM H20. GE-DATEX OHMEDA FIELD ENGINEER REPLACED ALL APL POPPET VALVES/DISKS IN ALL MACHINES WHICH RESULTED IN A FEW MONTHS OF NO PEEP PROBLEMS. RECENTLY THE PEEP PROBLEM HAS RETURNED AND GE-DATEX OHMEDA FIELD ENGINEER HAS NOW REPLACED ALL APL POPPET VALVES AND BLUE INSP./EXP. VALVE DISKS. GE-DATED OHMEDA WILL BE EVALUATING ALL OF THE APL AND INSP./EXP. VALVE DISKS IN ATTEMPT TO DETERMINE THE CAUSE OF THESE VALVES FROM STICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA ANESTHESIA MACHINE BSZ GENERAL ELECTRIC COMPANY/ DATEX-OHMEDA AESTIVA/5

    Patients

    Seq Age Sex Outcome Treatment
    1 YR