BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 179

    MDR report key: 12088426 · Received June 29, 2021

    Report

    Report Number
    8010042-2021-01547
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Report Date
    June 28, 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

    THE VENTILATOR WAS WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER ON-SITE. THE SUPPORT ARM WAS IDENTIFIED DEFECTIVE. NO PART HAS BEEN RETURNED TO MANUFACTURER FOR TECHNICAL INVESTIGATION. THE CAUSE OF THE REPORTED COMPONENT FAILURE HAS NOT BEEN ESTABLISHED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    MANUFACTURER REF#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANGLE ADJUSTMENT HANDLE OF THE SUPPORT ARM COMES OFF. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983699 SUPPORT ARM 179 SUPPORT, ARM IOY MAQUET CRITICAL CARE AB SUPPORT ARM 179

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose