BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 7876768 · Received September 14, 2018

    Report

    Report Number
    8010042-2018-00487
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    September 7, 2018
    Report Date
    April 3, 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 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 PERON: (B)(4). THE INVESTIGATION REGARDING THE REPORTED COMPLAINT HAS BEEN FINALIZED. THE REPORTED UNIT WAS INVESTIGATED BY OUR FILED SERVICE ENGINEER. THE DEVICE CONTROL PC (PRINTED CIRCUIT) BOARD WAS VERIFIED FAULTY AND WAS REPLACED AND SENT IN FOR INVESTIGATION. WHEN MOUNTED INTO A TEST DEVICE THE TECHNICAL ERROR CODE IS INSTANTLY REPRODUCED INDICATING VENTILATION DISABLED AND A COMMUNICATION FAILURE DURING STARTUP. INVESTIGATION VERIFIED THAT THE RETURNED CONTROL PC BOARD IS FAULTY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING A FAILURE OF THE CONTROL PRINTED CIRCUIT BOARD DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716682 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1