BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A350 SERIES CC

    MDR report key: 20045679 · Received August 23, 2024

    Report

    Report Number
    3019545235-2024-00028
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    May 7, 2024
    Report Date
    October 2, 2024
    Manufacturer
    SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.
    Product Code
    BSZ
    UDI-DI
    04048675643715
    PMA / PMN Number
    K230931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT IN (B)(6) 2024, THE PISTON DID NOT WORK DUE TO THE PERCEPTION OF THE AIRWAY PRESSURE SENSOR BEING 0 DURING USE IN MAY, NO PATIENT INVOLVED. THE PRESSURE SENSOR 100MBAR (PN 8605885) AND FILTER (PN 8603586) WERE REPLACED AND THE DEVICE WORKS WELL. THE FAILURE PART OF PRESSURE SENSOR 100MBAR WAS RETURNED FOR FURTHER INVESTIGATION. AFTER INVESTIGATION ON THE RETURNED PART, IT WAS CONFIRMED THERE WAS MALFUNCTION OF THE PRESSURE SENSOR 100MBAR. BASED ON THE FILED FAILURE OF THE PART INVOLVED, IT WAS NOT SYSTEMATICS ISSUE AND KEEP MONITORING. IN (B)(6) 2024, THE PISTON DID NOT WORK DURING USAGE, NO PATIENT INJURY. THE PARTS OF THE CONNECTOR BOARD (PN:8609141), THE UNDERPRESSURE PUMP COMPLETE (PN:8609260), THE KIT VENTILATOR ASSEMBLY (PN:8621410), THE BREATHING SYSTEM COMPLETE (PN:8621397) WERE REPLACED AND RETURNED FOR INVESTIGATION. AFTER INVESTIGATION, THE BREATHING SYSTEM COMPLETE WAS NOT DRAEGER 'S PRODUCT. INVESTIGATION ON THE KIT VENTILATOR ASSEMBLY IN THE LAB, NO FAILURE WAS REPRODUCED. INVESTIGATION ON THE CONNECTOR BOARD, NO FAILURE WAS REPRODUCED. INVESTIGATION ON THE UNDERPRESSURE PUMP COMPLETE, 'VENTILATOR MALFUNCTION, APNEA (NO FLOW)¿ OCCURRED. MULTIPLE TESTS WERE TAKEN IN LAB OVER FEW WEEKS, BY ANALYZING THE DEBUG CODES AND THE TESTS OF EACH MODULE, THE VENTILATION FAILURE COULD BE CAUSED BY THE FOLLOWING REASONS: 1. INAPPROPRIATE TUBE CONNECTION, LIKE BENDING, MAY BE TRIGGERED AS CLOGGED OR BLOCKAGE; 2. BAD CONNECTION OF CONNECTBOARD, THAT MAY CAUSE THE INACCURATE MEASUREMENT OF THE UNDERPRESSURE; BESIDES, THE MAINTENANCE OF THE DEVICE IS UNKNOWN AS IT WAS PROVIDED BY 3RD PART.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PISTON DID NOT WORK DUE TO THE PERCEPTION OF THE AIRWAY PRESSURE SENSOR BEING 0 DURING USE, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PISTON DID NOT WORK DUE TO THE PERCEPTION OF THE AIRWAY PRESSURE SENSOR BEING 0 DURING USE, NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256876 A350 SERIES CC ANESTHESIA UNITS BSZ SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. 2600000 NA 04048675643715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.| NA.