BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8151332 · Received December 11, 2018

    Report

    Report Number
    8010042-2018-00663
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Report Date
    February 11, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 (B)(4). CONTACT PERSON: (B)(4). OUR FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND INVESTIGATED THE REPORTED ISSUE. AS STATED IN THE SERVICE REPORT, THE VENTILATOR FAILED PRE-USE CHECK DUE TO A LEAKAGE. THE CUSTOMER INSTALLED A NEW PREVENTIVE MAINTENANCE KIT BUT THE VENTILATOR STILL DID NOT PASS THE TEST. THE FSE RESEATED THE PARTS AND MODULES MULTIPLE TIMES AND COULD NOT GET IT TO PASS AT FIRST. THEN, EVENTUALLY AFTER SOME OTHER ADJUSTMENTS, THE VENTILATOR PASSED THE PRE- USE CHECK. SEVERAL PRE-USE CHECKS WERE PERFORMED AND THE REPORTED ISSUE WAS NOT DUPLICATED. MACHINE PASSED ALL FUNCTIONAL TESTS AND RETURNED TO CLINICAL USE. NO PARTS WERE EXCHANGED IN THE SYSTEM AND LOGS WERE NOT PROVIDED. THE ISSUE WAS RELATED TO IMPROPERLY SEATED COMPONENT. THE HIGH O2 ISSUE WAS CLARIFIED AS BELOW BY OUR FSE AFTER A FOLLOW UP QUESTION. FSE STATED THAT THE HOSPITAL STAFF WAS RUNNING MEDICATION THROUGH THE UNIT WITH THE SAMPLE LINE CONNECTED AND THIS WAS CAUSING THE ANALYZER TO GIVE ODD READINGS WHICH WAS ONLY PRESENT AT THAT MOMENT.

    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).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR READ HIGH O2 AND FAILED INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989677 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1