BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S BASE UNIT

    MDR report key: 19583450 · Received June 21, 2024

    Report

    Report Number
    8010042-2024-01012
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Report Date
    June 21, 2024
    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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED BY OUR FIELD SERVICE ENGINEER. ACCORDING TO RECEIVED INFORMATION IN SERVICE REPORT, THE REPLACEMENT OF THE SUPPORT ARM 177 SOLVED THE ISSUE. THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE SUPPORT ARM SERVES TO RELIEVE THE PATIENT FROM THE WEIGHT OF THE TUBING SYSTEM. IT IS WORTH MENTIONING THAT CUSTOMER IS OBLIGED TO FOLLOW THE INSTALLATION INSTRUCTIONS DELIVERED TOGETHER WITH THE DEVICE. FOR EXAMPLE, ACCORDING TO INSTALLATION INSTRUCTIONS FOR THE SUPPORT ARM 177 (E.G. REV. 04) IN THE SPECIFICATION OF THE MAXIMUM CAPACITY, IT IS STATED HOW MANY KILOGRAMS CAN BE LOADED DEPENDING ON THE ANGLE OF USE OF THE ACCESSORIES (MAX. APPROX. 3 KG). WHEN MOVING THE SUPPORT ARM OR CHANGING POSITION, THE PATIENT CONNECTION SHOULD BE OBSERVED TO SEE THAT NO PULLING OR OTHER MOVEMENT OCCURS. THE CAUSE OF THE CLAIMED ISSUE IN THIS CUSTOMER PRODUCT COMPLAINT HAS BEEN DETERMINED. THE ISSUE WAS RELATED TO DEFECTIVE JOINTS OF SUPPORT ARM. THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015. A CORRECTION OF FIELDS # D1 BRAND NAME, D2 # PRODUCT CODE AND # COMMON DEVICE NAME, # D4 VERSION OR MODEL # AND CATALOG # WERE REQUIRED. D1 - BRAND NAME - PREVIOUS BRAND NAME: SUPPORT ARM 177, CORRECTED BRAND NAME: SERVO-S BASE UNIT. D2A - COMMON DEVICE NAME - PREVIOUS COMMON DEVICE NAME: SUPPORT, ARM, CORRECTED COMMON DEVICE NAME: VENTILATOR, CONTINUOUS, FACILITY USE. D2B - PRODUCT CODE - PREVIOUS PRODUCT CODE: IOY, CORRECTED PRODUCT CODE: CBK. D4 - VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: 6481720, CORRECTED VERSION OR MODEL #: 6640440. D4 - CATALOG # - PREVIOUS CATALOG #: 6481720, CORRECTED CATALOG #: BLANK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157589 SERVO-S BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6640440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown