BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 7483267 · Received May 3, 2018

    Report

    Report Number
    8010042-2018-00214
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    OUR COMPLAINT INVESTIGATION IS FINALIZED. OUR FIELD SERVICE ENGINEER (FSE)VISITED THE HOSPITAL AND CONDUCTED AN INVESTIGATION OF THE DEVICE. THE FSE CHECKED THE DEVICE LOG AND NOTICED THAT THE DEVICE GENERATED AN TECHNICAL ALARM FOR POWER ERROR ON FIRST OF MAY, THAT IS CONSIDERED TO BE THE ACTUAL EVENT DATE. FURTHER MORE FSE MEASURED THE POWER SUPPLY VOLTAGES AND DID NOT NOTICE ANY DEFICIENCY, THEREFORE NO ELECTRONIC COMPONENTS WAS REPLACED IN THE DEVICE. THE DEVICE WAS VERIFIED WITHOUT ISSUES AND THEREFORE RETURNED BACK TO CLINICAL USAGE. THERE HAS BEEN NO REOCCURRING ISSUES ON THIS DEVICE. THE POWER RELATED ALARM INDICATES THAT THE POWER INSIDE DIVE WAS TEMPORARY BELOW 21.5 VOLT AT THE TIME. WE HAVE NOT BEEN ABLE TO ESTABLISH THE ROOT CAUSE FOR THIS CONDITION. 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

    IT WAS REPORTED THAT THE VENTILATOR GAVE A TECHNICAL ERROR INDICATING POWER ERROR DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325332 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1