BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 18254492 · Received December 4, 2023

    Report

    Report Number
    8010042-2023-02350
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    October 20, 2023
    Report Date
    December 4, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE ON THE VENTILATOR WAS REQUESTED. THE USER FACILITY CONTACTED A THIRD-PARTY SERVICE PROVIDER FOR REPAIR WHO REPORTEDLY REPLACED THE NOZZLE UNIT IN THE O2 GAS MODULE. THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION AND NO VENTILATOR LOGS WERE PROVIDED. A PICTURE OF THE NOZZLE UNIT WAS PROVIDED SHOWING A BENT FEATHER SPRING. HOW OR WHEN THIS DAMAGE OCCURRED HAS NOT BEEN ABLE TO BE DETERMINED. THE NOZZLE UNIT IS A PART OF THE GAS MODULE AND REGULATES THE INSPIRATORY GAS FLOW TO THE PATIENT. IT CONSISTS OF A MEMBRANE, A MOUTHPIECE AND A FEATHER SPRING. THE MEMBRANE IN THE NOZZLE UNIT IS PRESSED AGAINST A MOUTHPIECE WITH A FEATHER SPRING TO REGULATE THE GAS FLOW THROUGH THE GAS MODULE. SINCE THE REPLACED PART WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    **DEVICE RELATED DATA QUALITY UPDATES ONLY** THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF UDI IN MANUFACTURING ON 2015-10-22. A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL #, # G4 PMA/510(K)#, # H4 MANUFACTURE DATE WERE REQUIRED. D1 - BRAND NAME - PREVIOUS BRAND NAME: SERVO-I, - CORRECTED BRAND NAME: SERVO-I BASE UNIT D4 - VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SERVO-I, - CORRECTED VERSION OR MODEL #: 6487800 G4 - PMA/510(K)# - PREVIOUS PMA/510(K)#: MISSING - CORRECTED PMA/510(K)#: K123149 H4 - MANUFACTURE DATE - PREVIOUS MANUFACTURE DATE: 02/13/2015 - CORRECTED MANUFACTURE DATE: 02/11/2015

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SURGERY FOR A SEVERE CRANIOCEREBRAL INJURY, THE PATIENT UNDERWENT VENTILATOR TREATMENT, AND THE INTRACRANIAL PRESSURE (ICP) WAS CONTINUOUSLY MONITORED. THE VENTILATOR GENERATED ALARMS FOR LOW O2 CONCENTRATION. THE PATIENT¿S ICP MONITORING SHOWED A PROGRESSIVE INCREASE, REACHING MORE THAN 35 MMHG. THE PATIENT WAS IMMEDIATELY PLACED ON ANOTHER VENTILATOR AND THE PATIENT¿S MONITORED ICP GRADUALLY DROPPED TO <20 MMHG. FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER¿S REF #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399668 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening