BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 6142908 · Received December 2, 2016

    Report

    Report Number
    2112667-2016-02346
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 4, 2016
    Report Date
    December 2, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. A QUOTE FOR REPLACEMENT OF THE POSITIVE END EXPIRATION PRESSURE (PEEP) VALVE AND A PREVENTIVE MAINTENANCE KIT WAS ISSUED BUT NOT ACCEPTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO OVER DELIVERY OF POSITIVE END EXPIRATORY PRESSURE (PEEP). THERE WAS HIGHER PEEP THAN EXPECTED, BUT NOT TO A REPORTABLE LEVEL. IF THERE IS AN INCREASE IN PEEP IN THE CIRCUIT, IT WILL BE DISPLAYED ON THE PRESSURE GAUGE AND ALSO VENTILATOR DISPLAY. THE SYSTEM IS DESIGNED TO ALARM, BASED ON USER SET PARAMETERS. THIS MALFUNCTION DID NOT RESULT IN A DEATH OR SERIOUS INJURY NOR WAS MEDICAL INTERVENTION REQUIRED. THIS EVENT IS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED HAVING PROBLEMS WITH THE POSITIVE END EXPIRATORY PRESSURE PERIMETERS. POSSIBLE OVER DELIVERY OF POSITIVE END EXPIRATORY PRESSURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793496 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1