BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 179

    MDR report key: 13024042 · Received December 17, 2021

    Report

    Report Number
    8010042-2021-02979
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Report Date
    December 17, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO REPAIR WAS REQUESTED AND NO PARTS WERE RETURNED. PICTURES WERE PROVIDED SHOWING THE FIXATION PLATE ON THE RAIL CLAMP THAT IS USED FOR FIXATING THE SUPPORT ARM ON THE VENTILATOR¿S SIDE RAIL HAD FALLEN OFF. THE ROOT CAUSE OF THE BROKEN SUPPORT ARM HAS NOT BEEN CONCLUSIVELY DETERMINED BUT MOST LIKELY HAS IT BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925003 SUPPORT ARM 179 SUPPORT, ARM IOY MAQUET CRITICAL CARE AB SUPPORT ARM 179

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose