BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 177

    MDR report key: 12679997 · Received October 22, 2021

    Report

    Report Number
    8010042-2021-02554
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 20, 2021
    Report Date
    October 22, 2021
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPPORT ARM WAS REPLACED BY OUR FIELD SERVICE ENGINEER BUT NOT RETURNED FOR INVESTIGATION. PROVIDED PICTURES CONFIRMED THE REPORTED BREAKAGE. 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. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. PREVIOUS INVESTIGATIONS OF SIMILAR FAULTS LED TO A REDESIGN AND CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THE SUPPORT ARM ASSOCIATED WITH THIS COMPLAINT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580750 SUPPORT ARM 177 SUPPORT, ARM IOY SUPPORT ARM 177

    Patients

    Seq Age Sex Outcome Treatment
    1