BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7175391 · Received January 9, 2018

    Report

    Report Number
    8010042-2018-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 14, 2017
    Report Date
    April 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PERON: (B)(4). OUR FIELD SERVICE ENGINEER (FSE)INVESTIGATED THE DEVICE AT THE EVENT SITE AND ISOLATED THE SMELL COMING FROM THE DC/DC & STANDARD CONNECTOR PRINTED CIRCUIT BOARD(PCB). NO PARTS WERE RETURNED FOR OUR INVESTIGATION. THE EVENT LOG CONFIRMS A TECHNICAL ERROR INDICATING THAT THE VENTILATOR DISPLAY WENT BLANK. OUR CONCLUSION IS THAT THERE WERE LIKELY AN ISSUE WITH REGARDS TO THE CONNECTING CABLE BETWEEN USER INTERFACE(PANEL)AND THE MONITOR SUB-SYSTEM. POSSIBLY, THE USER MAY HAVE TRIED TO RE-CONNECT THE LOOSE CABLE AND ACCIDENTALLY SHORT CIRCUIT-ED THE CONNECTING PINS AT THE DC/DC & STANDARD CONNECTOR PRINTED CIRCUIT BOARD(PCB)AND AS A CONSEQUENCE THE PRINTED CIRCUIT BOARD MALFUNCTIONED. THE DEVICE LOGS CANNOT CONFIRM IF THIS EVENT LEAD TO A COMPLETE SHUTDOWN OF THE DEVICE OR NOT, HOWEVER IT IS MORE LIKELY THAT THE PROBLEM ONLY AFFECTED THE MONITORING SIDE OF THE DEVICE(PANEL SUB-SYSTEM)THAN OTHER SUB-SYSTEMS. AS NO PARTS WERE RETURNED, WE CAN NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ¿MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CRITICAL CARE AB, (B)(4) A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN DURING PATIENT TREATMENT. THERE IS NO AVAILABLE INFO REGARDING PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19631 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1