BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 176

    MDR report key: 12735628 · Received November 2, 2021

    Report

    Report Number
    8010042-2021-02629
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 2, 2021
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS REQUESTED. THE SUPPORT ARM WAS REPLACED BY THE USER FACILITY AND NOT RETURNED FOR INVESTIGATION. NO PICTURES ON THE DAMAGES WERE PROVIDED. 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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634093 SUPPORT ARM 176 SUPPORT, ARM IOY SUPPORT ARM 176

    Patients

    Seq Age Sex Outcome Treatment
    1