BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 19674782 · Received July 4, 2024

    Report

    Report Number
    8010042-2024-01080
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 4, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON TECHNICIAN STATEMENT, THE ISSUE WAS RELATED TO CLAMP ATTACHMENT. THE CLAMP MOUNT IS A PART OF SUPPORT ARM AND IS MOUNTED DIRECTLY TO THE SERVO DEVICE. THE SUPPORT ARM SERVES TO RELIEVE THE PATIENT FROM THE WEIGHT OF THE TUBING SYSTEM. IN ORDER TO CONDUCT FURTHER ANALYSIS OF THE CASE, MORE DETAILED INFORMATION IS REQUIRED. UNFORTUNATELY, THE CLAIMED PART WAS NOT AVAILABLE FOR FURTHER ANALYZE. THEREFORE, THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED. A CORRECTION OF FIELD # D1 BRAND NAME, D2A COMMON DEVICE NAME, D2B PRODUCT CODE AND # D4 VERSION OR MODEL #, H4 - MANUFACTURE DATE WAS REQUIRED. D1 ¿ BRAND NAME: - PREVIOUS BRAND NAME: MISSING, - CORRECTED BRAND NAME: SERVO-I 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 #: MISSING. - CORRECTED VERSION OR MODEL #: 6487800. H4 - MANUFACTURE DATE: - PREVIOUS MANUFACTURE DATE: MISSING. - CORRECTED MANUFACTURE DATE: 09/17/2001. THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270533 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800
    179344 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown