BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8644160 · Received May 27, 2019

    Report

    Report Number
    8010042-2019-00351
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    May 21, 2019
    Report Date
    January 30, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FSE (FIELD SERVICE ENGINEER) WAS ON SITE AND INVESTIGATED THE REPORTED EVENT. THE EVENT IS DUPLICATED ON SITE. THE RECEIVED TEST LOG CONFIRMS THAT THE PRESSURE TRANSDUCER WAS MEASURING WRONG. THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARD WAS REPLACED BY OUR FSE AND THE VENTILATOR PASSED ALL THE FUNCTIONAL AND SAFETY TESTS AND RETURNED TO CLINICAL USE. THE RECEIVED TECHNICAL LOG DOES NOT CONTAIN ANY ERRORS THAT MAY INDICATE A VENTILATOR MALFUNCTION. THE INTERNAL LOG DOES NOT CONTAIN ANY RELEVANT INFORMATION ON THE GIVEN EVENT DATE. THE EXCHANGED PRESSURE TRANSDUCER PCB WAS NOT RETURNED FOR OUR INVESTIGATION THEREFORE THE FURTHER INVESTIGATION WAS NOT POSSIBLE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BEEN IDENTIFIED DUE TO LACK OF GOODS.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: 213430.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE AND PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436886 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1