BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7723926 · Received July 26, 2018

    Report

    Report Number
    8010042-2018-00380
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    THE INVESTIGATION OF THE REPORTED COMPLAINT HAS BEEN FINALIZED. INFORMATION RECEIVED FROM OUR SALES AND SERVICE UNIT STATES THAT THE FACILITY/HOSPITAL DOES ITS OWN TROUBLESHOOTING AND REPAIR. THE CONTROL PRINTED CIRCUIT BOARD WAS REPLACED AS A CORRECTIVE ACTION OF THE FAILED PRESSURE TRANSDUCER TEST. AFTER REPLACEMENT THEY GOT A TECHNICAL ERROR INDICATING COMMUNICATION FAILURE DURING STARTUP. THIS ERROR CODE MAY APPEAR AT THE FIRST STARTUP AFTER A SOFTWARE INSTALLATION (RESTART REQUIRED). THE FACILITY RESTARTED THE VENTILATOR AS THE SERVICE MANUAL REQUEST BUT THE MESSAGE WAS STILL PRESENT. THE FACILITY THEREAFTER REPLACED THE EXPIRATORY PRINTED CIRCUIT BOARD TO CORRECT THIS ERROR. OUR INVESTIGATION OF THE RETURNED EXPIRATORY PRINTED CIRCUIT BOARD DID NOT SHOW ANY DEVIATIONS, THE BOARD WAS FUNCTIONING ACCORDING SPECIFICATION WHEN SIMULATED USE TESTED. THE CONTROL PRINTED CIRCUIT BOARD WAS NOT RETURNED, DESPITE OUR EFFORTS IN OBTAINING IT BACK. ONE OF THE RECOMMENDED ACTIONS IN THE SERVICE MANUAL IS TO REPLACE THE CONTROL PRINTED CIRCUIT, IF THE PRESSURE TRANSDUCER TEST FAILS, BUT THERE ARE ALSO OTHER POSSIBILITIES GIVEN. AS THIS PRINTED CIRCUIT BOARD WAS NOT RECEIVED WE HAVE NOT BEEN ABLE TO ESTABLISH THE TRUE CAUSE OF THE REPORTED EVENT. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566810 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1