BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I BASE UNIT

    MDR report key: 19123382 · Received April 17, 2024

    Report

    Report Number
    8010042-2024-00630
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 17, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED BROKEN SUPPORT ARM HAS BEEN FINALIZED. THE EVALUATION OF THE PROVIDED PICTURES SHOWS THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM WAS MANUFACTURED BEFORE SEPTEMBER 2009. THE SUPPORT ARM IS A CASTING, AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. PREVIOUS INVESTIGATIONS LED TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. THE REPORTED SUPPORT ARM WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF THIS CHANGE. A CORRECTION WERE REQUIRED: D1 ¿ BRAND NAME ¿ PREVIOUS BRAND NAME: SUPPORT ARM 177. CORRECTED BRAND NAME: SERVO-I BASE UNIT D2 - PRODUCT CODE ¿ PREVIOUS PRODUCT CODE: IOY. CORRECTED PRODUCT CODE: CBK D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SUPPORT ARM 176. CORRECTED VERSION OR MODEL #: 6487800 D4 - SERIAL# - PREVIOUS SERIAL#: MISSING. CORRECTED SERIAL#: (B)(6) H4 - MANUFACTURE DATE ¿ PREVIOUS MANUFACTURE DATE: MISSING. CORRECTED MANUFACTURE DATE: 08/21/2008 THE UDI INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    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
    1023665 SERVO-I BASE UNIT VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6487800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown