BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8174308 · Received December 18, 2018

    Report

    Report Number
    8010042-2018-00679
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 28, 2018
    Report Date
    January 29, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4). THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). NO MALFUNCTION COULD BE FOUND. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. THE REVIEW OF PROVIDED DEVICE LOGS REVEALS THAT THE EVENT LOG DOES NOT COVER THE REPORTED DATE OF EVENT. HOWEVER, ON A LATER DATE, THE REPORTED ALARMS FOR LOW PEEP COULD BE FOUND IN COMBINATION WITH OTHER ALARMS THAT INDICATES THAT THE PRESSURE AND VOLUME DELIVERY IS RESTRICTED. THE TECHNICAL LOG COVERS THE DATE OF EVENT AND THERE ARE NO FINDINGS OF ANY TECHNICAL ERROR CODES THAT COULD INDICATE A DEVICE MALFUNCTION. THE TEST LOG SHOWS THAT THE DEVICE PASSED THE PRE-USE CHECK BOTH BEFORE AND AFTER THE REPORTED DATE OF EVENT. THE REPORTED TANDEM USE OF A HIGH FREQUENCY JET VENTILATOR (HFJV) IMPLIES THAT THE HFJV IS CONNECTED TO AN ET TUBE ADAPTER AND IT INDUCES A ¿JET¿ OF GAS OUT OF THE ADAPTER INTO THE AIRWAY. THE MEASURED INSPIRATORY VALUES WOULD BE AS PER THE SET PARAMETER VALUES BUT THE MEASURED EXPIRATORY VALUES WOULD INCLUDE THE VALUES OF THE HFJV AND THEREFORE, THE MEASURED EXPIRATORY VALUES WOULD NOT REFLECT THE PARAMETER SETTINGS AND WILL LEAD TO GENERATION OF APPROPRIATE ALARMS. THE USE OF A HFJV IN TANDEM WITH THE VENTILATOR HAS NOT BEEN TESTED, APPROVED, OR RECOMMENDED FOR USE WITH THIS VENTILATOR SYSTEM. THEREFORE THE CONSEQUENCES OF ITS USE WITH OUR VENTILATOR ARE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATION, ALARMS FOR HIGH PEEP WERE GENERATED WHEN THE VENTILATOR WAS USED IN TANDEM WITH A HIGH FREQUENCY JET VENTILATOR (HFJV). THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016741 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1